Teva Pharmaceuticals USA issues a voluntary user-level nationwide recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials

Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.

Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Based on available information it appears that all febrile or flu-like reactions were self-limiting with spontaneous resolution.

Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.

For use as an anesthetic agent, propofol should be used only by professionals trained in the administration of general anesthesia. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of critically ill patients.

Customers who have Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their distributor.

Teva Pharmaceuticals USA is voluntarily recalling the aforementioned lots. FDA and CDC have been apprised of this action.

Consumers with questions may contact 1-866-262-1243 from 8:00 am – 8:00 pm EDT Monday – Friday.

Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800 FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd.

U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public.”

This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. The FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective. Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov, or by telephone at 888-463-6332 or 301-796-3400.

The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. Today’s seizure is intended to lead to major changes at Caraco’s facilities.

If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public.

"The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements," said Michael Chappell, FDA acting associate commissioner for regulatory affairs.

Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.

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FDA Alerts Patients to Medtronic Pacemaker Recall

The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. Of those, only about 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer.

Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27.

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 800-505-4636 or going to their Web site at http://www.KappaSigmaSNList.medtronic.com.

Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Through standard medical device reporting requirements, the FDA became aware of possible problems and worked with the company to address them. The FDA classified this voluntary recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.

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AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability

A S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms.. Consequently, as a precautionary measure, A S Medication Solutions, LLC is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to the place of purchase.

Product Identification

Caraco Digoxin
A-S Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:
Digoxin Tablets, USP, 0.25 mg
54569-5758-0 (30-count)

Patients using A-S Medication Solutions, Digoxin tablets, USP, 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

Healthcare providers who have this product should return the product to their place of purchase. Healthcare providers can call A-S Medication Solutions Recall Coordinator at (847) 680-3515, Monday through Friday, 8:00 a.m. – 4:00 p.m. CST, for instructions on how to return the affected product or for any other inquiries related to this action.

Any adverse reactions experienced with the use of all affected product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test

Biosite Incorporated has initiated a voluntary, nationwide recall of one lot of Triage® Cardiac Panel. The test is used by healthcare professionals as an aid in the diagnosis of myocardial infarction (heart attack). The product has been recalled due to reports of low recovery of quality control samples containing Creatine Kinase MB (CK-MB), troponin I and myoglobin on the affected lot. Although there have been no reported issues of patient misdiagnosis associated with this lot to date, low recovery may lead to reporting of falsely low values for CK-MB, troponin I and myoglobin. A root cause investigation has been initiated.

The recall is limited to the Triage® Cardiac Panel, Catalog No. 97000HS, Lot #W44467B. Biosite Incorporated has notified its customers via overnight mail and has instructed them to discontinue use of the affected lot and discard any remaining product from the lot that is on hand. The identified lot was distributed to clinical labs in the United States between January and February 2009. Replacement product will be provided to clinical labs with remaining inventory of this affected product lot.

Biosite Incorporated has reported the action to the U.S. Food and Drug Administration.

As is noted in the package insert, the results of the Triage Cardiac Panel should not be used as absolute evidence of myocardial infarction and should be evaluated in the context of all the clinical and laboratory data available.

Customers with questions may contact the company at 1-877-441-7440, option 2 (24 hours a day, 7 days a week)

Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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FDA Warns Consumers to Stop Using Hydroxycut Products

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

–Online: www.fda.gov/MedWatch/report.htm
–Regular Mail: Use FDA postage paid form 3500 found at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
–Fax: 800-FDA-0178
–Phone: 800-FDA-1088

The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

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Arrow International Announces Worldwide Voluntary Recall of Intra Aortic Balloon Pump (IAB) Catheters

Teleflex Medical announced April 13 that the U.S. Food and Drug Administration (FDA) has classified the voluntary medical device recall initiated on February 2, 2009 by Arrow International’s Cardiac Care Division involving volume connectors for its 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters as a Class 1 recall. FDA defines Class I recalls as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

This recall is being conducted because a fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 cc or 5 cc, rather than the appropriate 30, 40, or 50 cc volume. In patients exhibiting moderate to severe myocardial ischemia or low perfusion states, prolonged exposure to the low default volume may fail to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure to a device which is inflated to less than 2/3 full could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.

Instructions contained in the operator’s manual fully describe the necessary warnings and precautions that will identify the issue. The recall notice restates these instructions and references the sections in the owner’s manual. If these instructions are followed, the issue for which the product was recalled can be discovered immediately, and the product can be removed and replaced.

Arrow International notified both domestic and foreign hospitals and distributors via an Urgent Medical Device recall letter dated February 2, 2009 that the company had become aware that the blue connector for the 40cc IAB was not properly recognized by the Arrow Intra-Aortic Balloon Pump (IABP) system. This recall involved the retrieval of unused product, issuance of mitigation instructions for patients and/or facilities in critical need, and the replacement of pump tubing assemblies.

At this time, there have been 25 complaints of this issue. There have been no reports of patient injury as a result of this issue. Approx. 423 lots are affected by this recall for a total 45,211 units.

PRODUCTS AFFECTED: 30/40/50 CC IAB Catheters:

PRODUCT CODES: IAB-04830-U, IAB-04840-U, IAB-05830-LWS, IAB05830-U, IAB-05840-U, IAB-05840-LWS, IAB06830-U, IAB06840-U, IAB-S730C, IAB-S840C, IAB-R950-U, IAK-02692, IAK-02693, and IAK-02691.

A list of products and lot numbers affected by this recall as well as the original recall notice can be found at Arrow’s website:

http://www.arrowintl.com/iab_recall.asp

Consumers with questions may contact the company at 1-800-523-8446; 8am to 8pm, ET, Monday through Friday, for international calls 001-919-361-4062; 8am to 5pm, ET, Monday through Friday.

Any adverse reactions experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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ETHEX Corporation Issues Voluntary Nationwide Recall

ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary expansion to the retail level of a previously announced recall on certain products. The recall on the products listed below had previously been issued to the wholesale level, but is now being expanded to the retail level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP). This additional level of recall is to further remove recalled products from the marketplace.

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

Expanded Recall to Retail Level Includes the Following Products:

* Morphine Sulfate Extended-Release Tablets 15mg, 30mg & 60mg (All Strengths)
* Morphine Sulfate Immediate-Release Tablets 15mg & 30 mg (All Strengths)
* Dextroamphetamine Sulfate Tablets 5mg & 10mg (All Strengths)
* Isosorbide Mononitrate Extended-Release Tablets 30mg, 60mg & 120mg (All Strengths)
* Propafenone HCl Tablets 150mg, 225mg & 300 mg (All Strengths)

Any retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.

Patients with questions about the recall should call the telephone number above, or contact their healthcare providers. Any adverse reactions experienced with the use of these products should also be reported to FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch .

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ETHEX Corporation Issues Voluntary Nationwide Recall Of Prescription Prenatal and Iron Supplements To Wholesale Level

ETHEX Corporation, a subsidiary of KV Pharmaceutical Company (NYSE: KVa/KVb), is issuing a voluntary nationwide recall of the products identified below (all lots within their expiration dates) at a wholesale level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP).

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medications may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to the Wholesale/Distributor Level:

Prescription Prenatal Vitamin Products:

Advanced NatalCare® Tablets
Advanced-RF NatalCare® Tablets
Cal-Nate™ Tablets
CareNatal™ DHA Tablets
ComBgen Tablets
ComBiRx™Tablets
NataCaps Capsules
NatalCare Gloss Tablets
NatalCare PIC Tablets
NatalCare PIC Forte Tablets
NatalCare Plus Tablets
NatalCare Rx Tablets
NatalCare Three Tablets
NataTab FA Tablets
NataTab RX Tablets
NutriNate® Chewable Tablets
NutriSpire™ Tablets
Prenatal MR 90 FE Tablets
Prenatal MTR w/Selinium Tablets
Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
Ultra NatalCare Tablets


Prescription Iron Supplement Products:

Anemagen Caplets
Anemagen Forte Caplets
Conison™ Capsules
Fe-Tinic™ 150 Forte Capsules

Any wholesaler inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.

Patients with questions about the recall should call the telephone number above, or contact their healthcare providers. Any adverse reactions experienced with the use of these products should also be reported to FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Ther-Rx Corporation Issues Voluntary Nationwide Recall Of Prescription Prenatal and Iron Supplements To Wholesale Level

Ther-Rx Corporation, a subsidiary of KV Pharmaceutical Company is issuing a voluntary nationwide recall of prescription prenatal and iron supplement nutritionals as identified below (all lots within their expiration dates) at a wholesale level. The Company is taking this action as a precautionary measure, because the products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practice (cGMP).

Patients who may have these products in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to the Wholesale Level:

Prescription Iron Supplement Products:

Chromagen® Caplet
Chromagen® FA Caplet
Chromagen® Forte Caplet
Encora® Capsule
Niferex® Gold Tablet
Niferex® 150 Forte Capsule
Repliva 21/7® Tablet

Prescription Prenatal Vitamin Products:

PreCare® Chewable Tablet
PreCare® Conceive Tablet
PreCare Premier® Tablet
PremesisRx® Tablet
PrimaCare® Capsule/Tablet
PrimaCare® Advantage™ Capsule/Tablet
PrimaCare® ONE Capsule

Any retail customer inquiries related to this action should be addressed to Ther-Rx Customer Service at 877-567-7676, or faxed to Ther-Rx Customer Service at (314) 646-3701, or e-mailed to info@ther-rx.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

Ther-Rx Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products, with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their healthcare providers.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the Company is unable to determine when distribution of these products will resume.

Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Ther-Rx Corporation Issues Nationwide Voluntary Recall of Products

Ther-Rx Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a voluntary nationwide recall of the products identified below (all lots within expiration) as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).

One of the products, Gynazole-1, was also distributed internationally to Eastern Europe, South America, Asia, and Canada.

Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to WHOLESALE Level:

Gynazole-1®, NDC 64011-0001-08
Clindesse®, NDC 64011-0124-08
microK® Extencaps® 8mEq 100, NDC 64011-0010-04
microK® Extencaps® 8mEq UD, NDC 64011-0010-11
microK® Extencaps® 8mEq 500, NDC 64011-0010-08
microK® Extencaps® 10mEq 100, NDC 64011-0009-04
microK® Extencaps® 10mEq UD, NDC 64011-0009-11
microK® Extencaps® 10mEq 500, NDC 64011-0009-08

Any customer inquiries related to this action should be addressed to Ther-Rx Customer Service at (877) 567-7676, or faxed to Ther-Rx Customer Service at (314) 646-3701, or e-mailed to info@ther-rx.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

Ther-Rx Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their health care providers.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the company is unable to determine when distribution of these products will resume.

Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/medwatch.

ETHEX Corporation Issues Nationwide Voluntary Recall of Products

ETHEX Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a nationwide voluntary recall of the products identified below (all lots within their expiration dates) at a wholesale or a retail level as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace.

Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to WHOLESALE Level:

Amlodipine Besylate Tablets, 10mg (58177-538-26 & 538-11)
Amlodipine Besylate Tablets, 2.5mg (58177-536-26)
Amlodipine Besylate Tablets, 5mg (58177-537-26, 537-07 & 537-11)
Benazepril HCl Tablets, 10mg (58177-342-04 & 342-08)
Benazepril HCl Tablets, 20mg (58177-343-04 & 343-08)
Benazepril HCl Tablets, 40mg, (58177-344-04 & 344-08)
Benazepril HCl Tablets, 5mg (58177-341-04)
Benzonatate Capsules, 100mg (58177-091-04 & 091-08)
Benzonatate Capsules, 200mg (58177-092-04 & 092-08)
Bromfenex ER Capsules (58177-019-04)
Bromfenex PD ER Capsules (58177-020-04)
Buspirone HCl Tablets, 10mg (58177-265-04 & 265-08)
Buspirone HCl Tablets, 15mg (58177-309-04 & 309-08)
Buspirone HCl Tablets, 5mg (58177-264-04 & 264-08)

Codeine Phosphate/Guaifenesin Tablets, 10mg (58177-223-04)
Dextroamphetamine Sulfate Tablets, 10mg (58177-312-04)
Dextroamphetamine Sulfate Tablets, 5mg (58177-311-04)
Dextroamphetamine Tablets, 10mg (58177-312-04)
Diltiazem HC1 Capsules, 120mg (58177-061-11)
Diltiazem HC1 Capsules, 120mg (58177-061-19 & 061-26)
Diltiazem HC1 Capsules, 180mg (58177-062-09 & 062-11)
Diltiazem HC1 Capsules, 180mg (58177-062-19 & 062-26)
Diltiazem HC1 Capsules, 240mg (58177-063-09 & 063-11)
Diltiazem HC1 Capsules, 240mg (58177-063-19 & 063-26)
Diltiazem HC1 Capsules, 300mg (58177-064-19 & 064-26)
Diltiazem HC1 Capsules, 360mg (58177-065-09 & 065-11)
Diltiazem HC1 Capsules, 360mg (58177-065-19 & 065-26)
Diltiazem HC1 Capsules, 420mg (58177-066-09 & 066-11)
Diltiazem HC1 Capsules, 420mg (58177-066-19 & 066-26)
Disopyramide Phosphate ER Capsules, 150mg (58177-002-04)
Doxazosin Mesylate Tablets, 1mg (58177-266-04 & 266-08)
Doxazosin Mesylate Tablets, 2mg (58177-267-04 & 267-08)
Doxazosin Mesylate Tablets, 4mg (58177-268-04 & 268-08)
Doxazosin Mesylate Tablets, 8mg (58177-269-04 & 269-08)
Ethedent Chewable Tablets, .25mg (58177-432-40)
Ethedent Chewable Tablets, .5mg (58177-433-40 & 433-09)
Ethedent Chewable Tablets, 1mg (58177-434-40 & 434-09)
EthexDerm BPW-10, 10% (58177-929-65)
EthexDerm BPW-5, 5% (58177-928-65)
Ethezyme 650 (58177-868-02)
Ethezyme 830 Papain-Urea (58177-816-02)
Ethezyme Papain-Urea (58177-804-02)
ETH-Oxydose Concentrated Solution (58177-914-04 & 914-56)
Guaifenex DM ER Tablets (58177-213-04)
Guaifenex GP ER Tablets (58177-373-04)
Guaifenex PSE 120 ER Tablets (58177-208-04)
Guaifenex PSE 60 ER Tablets (58177-214-04)
Guaifenex PSE 80 Tablets (58177-413-04)
Guaifenex PSE 85 Tablets (58177-478-04)
Hista-Vent DA Tablets (58177-227-04)
Hista-Vent PSE tablets (58177-426-04)
Histinex HC Liquid (58177-877-07 & 877-12)
Histinex PV Liquid (58177-883-07)
Hydrocodone Bitartrate & Acetaminophen Liquid (58177-909-07)
Hydrocodone Bitartrate/Guaifenesin Liquid (58177-881-07)
Hydrocortisone and Iodoquinol Cream, 1% (58177-803-02)
Hydroquinone 4% Cream w/SS, 1oz. (58177-802-02)
Hydroquinone 4% Cream, 1oz. (58177-801-02)
Hydro-Tussin CBX Liquid (58177-924-07)
Hydro-Tussin DHC Syrup (58177-926-07)
Hydro-Tussin DM Liquid (58177-906-07)
Hydro-Tussin EXP Liquid (58177-927-07)
HydroTussin HC Syrup (58177-915-07)
Hydro-Tussin Liquid (58177-890-07)
Hydro-Tussin XP Liquid (58177-916-07)
Hyoscyamine Orally Disintegrating Tablets, .125mg (58177-423-04)
Hyoscyamine Sublingual Tablets, .125mg (58177-255-04)
Hyoscyamine Sulfate ER Tablets, .375mg (58177-237-04)
Hyoscyamine Sulfate ER Capsules, .375mg (58177-017-04)
Hyoscyamine Sulfate Oral Tablets, .125mg (58177-274-04)
Isosorbide Mononitrate ER Tablets, 120mg (58177-201-04)

Isosorbide Mononitrate ER Tablets, 30mg (58177-222-04, 222-08 & 222-11)
Isosorbide Mononitrate ER Tablets, 60mg (58177-238-04, 238-08 & 238-11)
Meperidine/Promethazidne Capsules (58177-027-04)
Morphine InveAmp, 20mg x 1mL (58177-886-56)
Morphine InveAmp, 5mg/.25mL (58177-888-80)
Morphine Sulfate Concentrated Oral Solution 20mg/1ml (58177-886-01, 886-03 &886-05)
Morphine Sulfate Concentrated Oral Solution, 20mg/1ml (58177-886-57)
Morphine Sulfate ER Tablets, 100mg (58177-340-04)
Morphine Sulfate ER Tablets, 15mg (58177-310-04)
Morphine Sulfate ER Tablets, 200mg (58177-380-04)
Morphine Sulfate ER Tablets, 30mg (58177-320-04)
Morphine Sulfate ER Tablets, 60mg (58177-330-04)
Morphine Sulfate IR Tablets, 15mg (58177-313-04)
Morphine Sulfate IR Tablets, 30mg (58177-314-04)
NitroQuick Sublingual Tablets, .3mg (58177-323-04)
NitroQuick Sublingual Tablets, .4mg (58177-324-18 & 324-04)
NitroQuick Sublingual Tablets, .6mg (58177-325-04)
Nystatin Topical Powder, USP 15 grams (58177-839-45)
Nystatin Topical Powder, USP 30 grams (58177-839-46)
Nystatin Topical Powder, USP 60 grams (58177-839-61)
Ondansetron Orally Disintegrating Tablets, 4mg (58177-363-22)
Ondansetron Orally Disintegrating Tablets, 8mg (58177-364-22 & 364-56)
Oxycodone HCl Capsules, 5mg (58177-041-04 & 041-11)
Oxycodone HCl IR Tablets, 10mg (58177-461-04)
Oxycodone HCl IR Tablets, 15mg, (58177-445-04)
Oxycodone HCl IR Tablets, 20mg (58177-462-04)
Oxycodone HCl IR Tablets, 30mg (58177-446-04)
Oxycodone HCl IR Tablets, 5mg (58177-625-04 & 625-11)
Pangestyme CN 20 (58177-030-04)
Pangestyme CN10 (58177-029-04)
Pangestyme EC 100 (58177-031-04)
Pangestyme EC 250 (58177-031-06)
Pangestyme MT16 (58177-028-04)
Pangestyme UL12 (58177-048-04)
Pangestyme UL18 (58177-049-04)
Pangestyme UL20 (58177-050-04)
PhenaVent Capsules (58177-078-19)
PhenaVent D Tablets (58177-444-04)
PhenaVent LA Capsules (58177-095-19)
PhenaVent PED Capsules (58177-079-04)
Plaretase 800 (58177-416-04 & 416-08)
Potassium Chloride ER Capsules, 10mEq (58177-001-04, 001-08, 001-09, & 001-11)
Potassium Chloride ER Capsules, 8mEq (58177-677-04 & 677-08)
Potassium Chloride ER Tablets, 20mEq (58177-202-04, 202-08, 202-09 & 202-11)
Prednisolone Sodium Oral Solution (58177-932-05)
Prednisolone Syrup 15mg/5mL (58177-910-05 & 910-07)
Prednisolone Syrup 5mg/5mL (58177-912-03)
Propafenone HCl Tablets, 150mg (58177-331-04 & 331-11)
Propafenone HCl Tablets, 225mg (58177-332-04)
Propafenone HCl Tablets, 300mg (58177-333-04)
Pseudovent 400 Capsules (58177-096-04)
Pseudovent Capsules (58177-045-04)
Pseudovent PED Capsules (58177-046-04)
Tri-Vent DM Syrup (58177-925-07)
Tri-Vent DPC Liquid (58177-923-07)
Tri-Vent HC Liquid (58177-920-07)

Products Recalled to RETAIL PHARMACY Level:

Hydromorphone HCl Tablets, 2mg (58177-620-04 & 620-11)
Hydromorphone HCl Tablets, 4mg (58177-621-04 & 621-11)
Hydromorphone HCl Tablets, 8mg (58177-449-04)
Metoprolol Succinate ER Tablets, 50mg (58177-369-04, 369-09 & 369-11)
Metoprolol Succinate ER Tablets, 100mg (58177-368-04, 368-09 & 368-11)
Metoprolol Succinate ER Tablets, 25mg (58177-293-04, 293-09 & 293-11)
Metoprolol Succinate ER Tablets, 200mg (58177-358-04, 358-09 & 358-11)

Any wholesale or retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers (and to retailers for Hydromorphone HCl and Metoprolol Succinate only) nationwide who received any inventory of the recalled products with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their healthcare providers.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the company is unable to determine when distribution of these products will resume.

Any adverse reactions experienced with the use of these products should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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FDA Announces Class I Recall of Ophthalmic Surgical Device

The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif.

OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.

However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States.

AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.

The FDA urges anyone in possession of any units from the recalled lot, whether units were purchased from the company or provided as a sample by a sales representative, to remove them from inventory, and contact AMO at 1-877-AMO-4Life to make arrangements for return. The lot number of the device is displayed on the side panel of each unit.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to AMO by calling 1-877-AMO-4LIFE and to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD, 20852-9787
Fax: (800) FDA-0178
Phone: (800) FDA-1088

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Stryker Craniomaxillofacial Issues Nationwide Recall of its Custom Cranial Implant Kits

Stryker Craniomaxillofacial Issues Nationwide Recall of its Custom Cranial Implant Kits; Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile
Stryker's Craniomaxillofacial (CMF) business unit announced today that the U.S. Food and Drug Administration (FDA) concluded on Dec. 18, 2008 that its recall of the following Stryker CMF's Custom Cranial Implant Kits is a Class I recall, which means the product could pose an imminent hazard to health: Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile.

The notification relates to a nationwide voluntary recall initiated by Stryker CMF on Oct. 24, 2008 of 322 Custom Cranial Implant Kits after determining that the sterilization validation of the product was not performed according to appropriate standards. Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis, re-operation with revision of cranioplasty, long-term neurological deterioration, additional hospitalization, or long-term intravenous antibiotic treatment. Death can occur if an infection is not diagnosed quickly.

Physicians and hospitals who have product that corresponds to the catalogue numbers listed above should stop implanting the product immediately and return it to Stryker CMF. Stryker recommends that patients who have received these implants be monitored by their physicians for signs of infection for at least six months post-implantation.

Stryker CMF previously notified implanting surgeons, hospital risk managers and its sales representatives of the potential health risks associated with the kits and requested that they return any remaining products to Stryker CMF. Stryker CMF will again notify implanting surgeons, risk managers and its sales representatives of this recall and its potential health risk and request that physicians or hospitals return to Stryker CMF any of this product that has not been implanted.

Physicians and patients with questions related to this issue should contact Stryker CMF at 800-962-6558, Monday – Friday, 8 a.m. to 7 p.m. ET. Patients with questions are encouraged to speak with their surgeon. Any adverse events relating to this product should be reported to Stryker.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Stryker Corporation is one of the world's leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. For more information about Stryker, please visit www.stryker.com.

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ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet

ETHEX Corporation announced today that it has voluntarily recalled to the consumer level, a single production lot of Hydromorphone HCl 2 mg tablets (Lot #90219, Exp: 03/2010; NDC #58177-0620-04), as a precaution, due to the possibility it may contain oversized tablets. Hydromorphone is a drug used for pain management and is packaged under the ETHEX label in 100-count bottles.

If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation.

There are other companies in the United States producing and marketing versions of Hydromorphone HCl tablets and consumers and their caregivers are encouraged to check their prescriptions to determine the source of their tablets. Hydromorphone HCl 2 mg tablets marketed by ETHEX are a blue, round tablet with a script "E" on one side and a "2" on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers nationwide who have received any inventory of the recalled lot of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact ETHEX as provided below regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the telephone number below or their physician, pharmacist, or other health care provider.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472 or fax to ETHEX Customer Service at 314-646-3751, or e-mail to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST. Consumers who experience any adverse reactions to this drug should contact their physician and/or healthcare provider immediately. Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

The Hydromorphone HCl recall announcement is posted on www.kvpharmaceutical.com and www.fda.gov/opacom/7alerts.html. It includes step-by-step details on how to return affected product to KV Pharmaceutical. The Company web site also includes a list of the drugs affected by the suspension.

The parent company of ETHEX Corporation, KV Pharmaceutical has advised the U.S. Food and Drug Administration that, effective midnight Dec. 19, 2008, the company voluntarily suspended shipments of all FDA-approved drug products in tablet form. This action is being taken as a precautionary measure, to allow KV to expeditiously address manufacturing issues that have come to management’s attention, to review and enhance comprehensively the company’s quality systems, and to implement efficiency improvements in its production facilities. KV is keeping the FDA informed about the Company’s plans.

This recall and suspension are being conducted with the knowledge of the FDA. At this time, the company is unable to determine when distribution of tablet form products will resume, or estimate what the financial impact of the recall and suspension will be.

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FDA Announces Class I Recalls of Two Unapproved Devices

The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death.

The manufacturers, VIBE Technologies of Greeley, Colo., and Nebion LLC of Los Angeles, Calif., claimed their devices treated conditions ranging from cancer to migraines. The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.

"These recalls underscore the importance of taking action against manufacturers who make false medical claims for their devices," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "One of the FDA's primary responsibilities is protecting consumers from harm that can be caused by manufacturers who try to sidestep the approval and clearance process.”
Vibrational Integrated Bio-photonic Energizer device

On April 11, 2008, the FDA issued a warning letter to VIBE Technologies stating that the agency's November 2007 inspection of the facility showed that the company had not obtained FDA marketing approval or clearance for the Vibrational Integrated Bio-photonic Energizer (VIBE device), which claims to treat cancer, infections, and depression. The FDA also cited the company for substantial deviations from the current Good Manufacturing Practice/Quality System regulation.

VIBE Technologies initiated a recall of 840 VIBE devices in an April 3, 2008, letter sent to users. VIBE Technologies agreed to stop promoting and marketing the VIBE device, and will contact all those who had purchased it to ensure no other unsubstantiated medical claims are being made. The FDA has requested that the company update its recall notices to state that the VIBE device is not intended for the treatment of any diseases or medical conditions.

The FDA is aware of information that suggests that the VIBE device has been used in cancer patients. There is one death that occurred in a patient who used this device. However, FDA has not verified that there is any association between the death and the VIBE device.
HLX8 device

In June 2008 FDA inspected Nebion, LLC, which revealed that the company had not obtained FDA marketing approval or clearance for the HLX8 device, which claims to treat cancer, migraines, arthritis, and ruptured discs. The inspection also uncovered substantial deviations from the Current Good Manufacturing Practice/Quality System regulation.

Nebion recalled eight HLX8 devices on July 2, 2008, and notified their customers to stop using the devices immediately and to contact Nebion for their retrieval.

Nebion's first recall letter did not address the potential risks associated with the HLX8 device, but the company has recently notified FDA that they will issue a second letter that identifies potential health hazards. The FDA has not received any reports of injuries or deaths linked with the HLX8 device.

Under federal law, products that claim to diagnose a disease or condition, cure, mitigate, treat or prevent disease, or that are intended to affect the structure or function of the body are devices subject to FDA jurisdiction and may require FDA approval or clearance prior to marketing. Premarket approval is the most stringent type of FDA device review and is for devices with a high level of risk, such as those that support or sustain human life. FDA clearance is for lower risk devices that are shown to be as safe and effective as a similar device already on the market.

Neither VIBE Technologies nor Nebion has demonstrated to the FDA that their device is safe and effective at curing or treating diseases as claimed.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: (800) FDA-0178
* Phone: (800) FDA-1088

Health care professionals and patients can obtain further details about the recalls from VIBE Technologies at 970-356-9594 or Nebion LLC, at 310-215-6400.

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Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP

Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code Label

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is following up on a nationwide voluntary recall issued Sept. 18 of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers because a small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion.

The product contains 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride. The product name and National Drug Code (NDC) number printed on the container are correct. The affected lot was shipped to U.S. customers between July 2008 and September 2008. No other lots are affected by this recall.

Hospira has not received any reports of adverse health events in connection with the recalled lot. Hospira has identified the root cause of the error and taken action to prevent its recurrence.

Anyone with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it. Customers who have medical questions should contact Hospira Medical Communications at 1-800-615-0187. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Terumo Cardiovascular Systems Issues Urgent, Nationwide/Worldwide Recall of Pediatric Arterial Cannulae

Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, nationwide/worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae involving 21 lot codes (see information below). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.

There have been no reports of patient injury or death associated with the product.

Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected

Catalog Number Lot Number

813568 0501639, 0512002

813567 0501557, 0512008

813570 0502200, 0513069

813569 0502199, 0513068, 0517852

813572 0507121, 0512918

813571 0507120, 0512919, 0518680

813574 0509240

813573 0509238, 0517874

813576 0509241

813575 0500759, 0513331

813578 0500760

813577 0502878

An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.

Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe. The notification letter recommended that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. Clinicians with questions may contact the company at 800-521-2818, or if calling from outside the U.S., 734-663-4145. Contact can be made Monday-Friday from 8:00 a.m. to 5:00 p.m. EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 1-800-FDA-0178

Terumo informed the U.S. Food and Drug Administration of this recall. Terumo Cardiovascular Systems Corporation is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; Ashland, Massachusetts; and Tustin, California. For more information, visit www.terumo-cvs.com.

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Johnson & Johnson-Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall of Infants' MYLICON(R) GAS RELIEF DYE FREE Drops

Johnson & Johnson-Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall of Infants' MYLICON(R) GAS RELIEF DYE FREE Drops (Simethicone-Antigas) Non-Staining Due to Possible Metal Fragments

PRNewswire/ -- Johnson & Johnson-Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON(R) GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Product
Code # Lot # Exp Product
71683791111-1 SMF007 09/10 Infants' Mylicon(R) Gas Relief Dye Free
Non-Staining Drops 1 oz.

71683791111-1 SMF008 09/10 Infants' Mylicon(R) Gas Relief Dye Free
Non-Staining Drops 1 oz.

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday -- Friday, 8:00 a.m. -- 8:00 p.m. EST) or via the internet at http://www.mylicon.com/ for instructions regarding how to dispose of the product and request a replacement or refund.

Infants' MYLICON(R) drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants' MYLICON(R) GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: Use postage-paid FDA form 3500 available at:
http://www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787

Fax: 1-800-FDA-0178

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FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

The FDA urges patients and health care professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.

Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

ReliOn Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe.

During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.

The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008.

Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its Web site, and sent letters to more than 16,500 customers notifying them of the recall.

The manufacturer has received one adverse report related to a syringe from this product lot.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

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