Dr Reddy's recalls over
13,000 bottles of hypertension drug- FDA
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[June 19, 2014]
MUMBAI (Reuters) - India's
Dr Reddy's Laboratories Ltd is recalling 13,560 bottles
of the high blood pressure drug metoprolol succinate in
the United States after it failed a dissolution test,
the U.S. Food and Drug Administration said.
Metoprolol succinate extended release is a cheaper generic form of
AstraZeneca Plc's Toprol XL. Wockhardt Ltd also recalled 109,744
bottles of the same drug last month citing the same reason.
The recall was voluntarily started by Dr Reddy's on May 23, 2014,
and posted on the FDA website on Thursday.
A Dr Reddy's spokesman did not immediately respond to a request for
comment on the recall.
Dissolution tests are commonly conducted to check the time taken for
the active ingredient in a drug to release into the body, and help
predict how the drug performs inside the body.
The Dr Reddy's recall, like the one by Wockhardt, was classified by
the FDA as Class II, which means use of or exposure to the recalled
products may cause temporary or medically reversible adverse health
This is the latest in a string of drug recalls and manufacturing
quality-related issues involving Indian companies that have hurt the
reputation of the industry as a supplier of cheap generic drugs, and
led to increased scrutiny from regulators.
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Dr Reddy's recalled about 58,656 bottles of the heartburn drug
lansoprazole in the United States in March due to a microbial
(Reporting by Zeba Siddiqui in Mumbai; Editing by Sunil Nair)
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