ANTI-ALLERGIC DRUGS RECALLED BY ZYDUS CADILA FROM US MARKET

New Delhi, June 12, 2014 – Zydus Cadila issued a voluntary recall of nearly 10,200 bottles of an anti-allergic drug from the US market. The recall was started by the company’s US unit, Zydus Pharmaceuticals USA Inc. due to the presence of the high blood pressure medicine atenolol in a bottle containing the allergy drug, promethazine hydrochloride.

Promethazine hydrochloride is commonly used to treat allergic reactions and to treat or prevent nausea and vomiting from illness or motion sickness. It is also used to make you sleep (sedative) before surgery, and to help treat pain or nausea after surgery. Its use is coupled with common side effects, which include drowsiness, dizziness, and problems with balance, blurred vision, insomnia, or shakiness.

The FDA classified the recall as 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.” The Zydus spokesperson said that it was a voluntary recall by the company as a precautionary measure. The potentially mixed bottles of medication that are being recalled have an expiration date of September 2015. IGMPI