India's Zydus Cadila
recalls over 10,000 bottles of allergy drug in U.S
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[May 30, 2014]
MUMBAI (Reuters) - Indian
drugmaker Zydus Cadila is recalling 10,200 bottles of an
allergy-relief drug in the United States after another
drug for high blood pressure was found in one of the
bottles, the U.S. Food and Drug Administration said on
The recall was voluntarily started by the company's U.S. unit, Zydus
Pharmaceuticals USA Inc, on May 8, 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
disorders, nausea, vomiting and difficulty sleeping, as well as for
The FDA classified the recall as Class II, which means use of or
exposure to the recalled products may cause temporary or medically
reversible adverse health consequences.
The bottles being recalled carry an expiry date of September 2015,
according to the FDA post. (http://r.reuters.com/xaf79v)
"This was a voluntary recall by the company as a precautionary
measure," a Zydus spokeswoman said in an email to Reuters.
Recalls of drugs are not uncommon.
However, Zydus's drug recall is the seventh this year by an Indian
company, and follows those by other large drugmakers including
Wockhardt Ltd, Ranbaxy Laboratories Ltd, Dr. Reddy's Laboratories
Ltd, Lupin Ltd, Sun Pharmaceutical Industries Ltd and Glenmark
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The incidents come at a time when the FDA has increased its scrutiny
of Indian drugmakers after the agency banned exports from
manufacturing plants of some top drugmakers, including Ranbaxy and
Wockhardt, upon finding quality control lapses.
(Reporting by Zeba Siddiqui in Mumbai; Editing by Subhranshu Sahu)
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