A recall of Metronidazole has been issued by Teva Pharmaceuticals due to potentially undersized pills, which may result in consumers not receiving the full dose of the prescribed antibiotic.
The Metronidazole recall was announced by the FDA on Thursday after underweight pills were detected in one lot. The tablets may not contain the full amount of the active ingredient in the pill.
Metronidazole is used to treat a number of anaerobic bacterial infections, as well as symptomatic and asymptomatic trichomoniasis, asymptomatic consorts and amebiasis. If a patient does not receive a full dose it could cause the infection to worsen or return, which could be life-threatening if the infection was severe. There have been no adverse events reported in connection to the Metronidazole recall.
The recall affects lot 312566 of Metronidazole Tablets USP, 250 mg, by Teva Pharmaceuticals. They were sold in 250-count bottles and have an expiration date of 05/2012.
Wholesalers and retailers have been alerted to the recall by mail and given instructions on returning the defective Metronidazole pills. They should inspect their inventory for the recalled pills. Consumers who have the pills should stop taking them and return them to their pharmacy.
A number of U.S. generic drug makers have experienced manufacturing problems in recent years involving oversized or undersized pills.
In April 2008, a Digitek recall was issued for all lots of the generic heart drug digoxin manufactured by Actavis Totowa at their New Jersey facility. According to FDA adverse event reports, at least 667 digoxin deaths were reported among users of the drug who claimed that problems were associated with receiving too much of the medication.
That same year, all generic drugs manufactured by Ethex Corp. were recalled due to manufacturing problems which led to oversized tablets of morphine and other drugs being distributed. This exposed consumers to a potential risk of a morphine overdose from the oversized tablets.
In 2009, Caraco Pharmaceutical Laboratories issued a generic digoxin recall for their version of the heart drug, due to manufacturing problems at their Michigan facilities which allowed some pills to contain too much or too little of the active drug. In June of that year, after the FDA identified continued problems with the drug maker adhering to the current Good Manufacturing Practice requirements, U.S. Marshalls shutdown Caraco’s production facilities and seized their inventory.
