May 30, 2014 — Indian drug-maker Zydus Pharmaceuticals is recalling 10,200 bottles of anti-allergy pills in the United States because they may contain the wrong drug.
The U.S. Food and Drug Administration (FDA) issued the recall after finding a 25-mg tablet of atenolol in a bottle that should have contained 25-mg tablets of promethazine hydrochloride.
Promethazine is primarily an allergy-relief medication, but it is also used to treat nausea, vomiting, problems sleeping, and for pre-operative sedation. Atenolol is a medication that decreases blood-pressure, prevent chest pain (angina), and improve survival after a heart attack.
Zydus initiated the recall on May 8. The FDA classifies it as a Class II recall, which means the potential health consequences are likely to be temporary and medically-reversible.
Recalled medications include:
- PROMETHAZINE HYDROCHLORIDE: Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Lot #: MN9081, Expiry: 09/2015.
Reuters reports that this is the seventh time an Indian drug-maker has recalled drugs this year. The FDA has recently stepped up inspections of Indian facilities involved in ingredient production and formulation. The agency is concerned about quality control issues. They have already banned imports from some top drug-makers, including facilities owned by Ranbaxy and Wockhardt.
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