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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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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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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ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets

ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

If someone were to take a higher than expected dose of Dextroamphetamine Sulfate, then the risk of adverse effects known to be associated with the drug such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and dry mouth may be increased.

No report of any oversized Dextroamphetamine Sulfate tablets has been received by ETHEX from any wholesaler, retailer, consumer or caregiver, and ETHEX has not received any report of unexpected side effects or injury related to this product.

ETHEX Corporation is conducting this precautionary, voluntary recall because it found a small number of oversized tablets in lots which had not yet been distributed. These oversized tablets were removed before the lots were distributed.

Please be aware that there are multiple companies in the United States producing and marketing generic versions of Dextroamphetamine Sulfate 5 mg tablets and consumers and their caregivers are encouraged to check their prescriptions to determine the source of their tablets.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers nationwide who have received any inventory of the recalled lots 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 above regarding procedures for returning the recalled product. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized. If consumers have any questions about the recall, they should call the telephone number above, their physician, their pharmacist or other health care provider.

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 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.

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