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FDA Alert: Class II Recall Issued on Hypertension Pill Found in Allergy Drug Bottles

The Indian drug-manufacturer, Zydus Cadila, has recalled 10,200 bottles of its allergy-relief medication from the United States after it found one of its 25 mg bottles contaminated with 25 mg of atenolol, a medication used to treat hypertension (high blood pressure) and angina (chest pain).  The FDA classified the recall as a Class II, which means it “involves a potential health hazard situation where there is remote probability of adverse health consequences from the use of the product.” A Zydus spokeswoman said that the recall by the company was simply a precautionary measure.

Promethazine is used as an oral medication to treat certain allergic reactions, difficulty sleeping, nausea and vomiting, or pain after surgery or childbirth. Common side effects include drowsiness, dizziness, problems with balance, blurred vision, insomnia, or shakiness.

Earlier in June 2013, Zydus Cadila’s US subsidiary had voluntarily recalled one lot of warfarin 2 mg tablets when some of those tablets were found to be oversized. Zydus’s recall is the seventh recall that has occurred this year by an India-based drug company, along with major recalls from other drug manufacturers, such as those by Wockhardt, Sun Pharmaceuticals, and Ranbaxy Laboratories.


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