AUDIENCE: Pharmacy, Consumer
ISSUE: Teva Pharmaceuticals and FDA notified healthcare professionals and the public of a recall of Metronidazole Tablets USP, 250mg, lot #312566, expiration date 05/2012. This product lot is being recalled due to the presence of underweight tablets. Underweight tablets may not contain the full amount of active ingredient within a single tablet, and a consumer may not receive the prescribed dose. This may cause the infection the drug was intended to treat to worsen or recur, which could be life-threatening when treating severe infections.
BACKGROUND: Metronidazole is indicated for the treatment of symptomatic and asymptomatic trichomoniasis, and treatment of asymptomatic consorts, amebiasis and a variety of anaerobic bacterial infections. The affected Metronidazole lot is packaged in 250 count bottles and was distributed nationwide to wholesalers and retailers.
RECOMMENDATION: Consumers who have lot 312566 in their possession are instructed to cease using the product and return it to their pharmacy.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/06/2011 - Press Release - Teva Pharmaceuticals, U.S.A]