Teva Pharmaceuticals, U.S.A, is voluntarily recalling Metronidazole Tablets USP, 250mg, lot 312566, expiration date 05/2012, the FDA announced. 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, 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. To date, Teva Pharmaceuticals, U.S.A. has not received any adverse events associated with the use of this product lot.
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.
Wholesalers and retailers have been previously notified of this recall via overnight notification on 10/25/10 and are in the process of returning this product lot.
Consumers who have lot 312566 in their possession are instructed to cease using the product and return it to their pharmacy. Wholesalers and retailers should cease distribution and examine their inventory immediately.