May 30, 2014 — The U.S. Food and Drug Administration (FDA) has issued a recall for about 10,200 bottles of promethazine hydrochloride, an allergy-relief drug that may have been mixed up with atenolol, a high blood-pressure drug.
The voluntary recall was initiated on May 8 by Zydus Pharmaceuticals USA, the American unit of Zydur Cadila, an Indian drug-maker. The FDA has categorized the recall as Class II, which means exposure to the recalled products may cause temporary medically-reversible side effects.
Products affected by the recall include:
- PROMETHAZINE HYDROCHLORIDE: Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Lot #: MN9081, Expiry: 09/2015.
Promethazine hydrochloride is commonly used to treat allergic disorders, nausea, vomiting, problems sleeping, and for pre-operative sedation. Atenolol is used to treat high blood pressure, prevent chest pain (angina), and improve survival after a heart attack.
According to Reuters, this recall is the seventh from an Indian drug-maker this year. The FDA is concerned about quality-control issues and they have banned imports from some top drug-makers, including Ranbaxy and Wockhardt. The FDA is also stepping up inspections of Indian facilities in the coming weeks, including export-oriented ingredient plants and two formulation plants.
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