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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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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