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Recalls from U.S. Drug Market by Wockhardt, Sun Pharma

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Published on : Aug 31, 2015

A voluntary drug recall was made by Sun Pharma to retrieve shipments of a drug released to the U.S. markets. Extended-A-release pills of Bupropion Hydrochloride have been recalled for “failure to specify dissolution”. The USP (SR), 200 mg, 60 count bottles have currently been taken off U.S. shelves. Meanwhile, Wockhardt has also made a recall of 5 mg and 20 mg tablets of Lisinipril, citing “CGMP violations”.

A notification was delivered by the U.S. FDA, which said Sun Pharma had initiated a recall in July through a Class 3 classification clause. The classification read ‘an instance of exposure or use to a product that is violative, not likely to create negative effects of health’.

Bupropion Hydrochloride is an antidepressant that is used to cure high levels of depressive disorders as well as seasonal affective disorder.

The U.S. FDA had mentioned on its website the failure to specify dissolution throughout an 18 month testing of long term stability. In the tests, it was witnessed that the release results of Bupropion Hydrochloride after exactly 4 hours were not matching to the product specifications.

More than 35,000 bottles of the antidepressant – each bottle being a 60 count one – that were distributed by Sun Pharma have successfully been recalled. Spokespersons for the pharmaceutical company were not available for comment.

The FDA has also said Wockhardt Limited has initiated its own voluntary recall of nearly 5,000 bottles of Lisinopril tablets of 20 mg and 5 mg from U.S. shelves. The drugs have been manufactured in their Indian facilities.

Lisinopril is used to treat adult hypertension in adults as well as children. It works by lowering blood pressure.