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Business News/ Industry / Manufacturing/  Sun Pharma recalls some generic drug batches in US
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Sun Pharma recalls some generic drug batches in US

Ranbaxy also pulls two batches of its version of Pfizer's Lipitor cholesterol- lowering drug from the US market

Sun Pharma is recalling a batch of generic diabetes tablets after a customer complained of finding pills of an epilepsy medication mixed in. Photo: MintPremium
Sun Pharma is recalling a batch of generic diabetes tablets after a customer complained of finding pills of an epilepsy medication mixed in. Photo: Mint

Mumbai: Indian generic-drug maker Sun Pharmaceutical Industries Ltd. has recalled some batches of drugs in the US after complaints of bottling mix-ups.

Sun Pharma is recalling a batch of generic diabetes tablets after a customer complained of finding pills of an epilepsy medication mixed in. Separately, rival Ranbaxy Laboratories Ltd. pulled two batches of its version of Pfizer Inc.’s Lipitor cholesterol- lowering drug from the US market. Both recalls were listed in the Food and Drug Administration’s enforcement report for the week of 5 March.

FDA officials have said they plan to tighten rules on how they regulate the generic-drug industry as a way to convince American consumers that safeguards are in place. Generic drugs, which make up almost 80% of the medicine used in the US, helped Americans save $193 billion in 2011 as health-care costs rise and insurers force more consumers to use them.

Sun initiated a voluntary recall of 2,528 bottles of metformin hydrochloride extended release tablets after a customer complained of the presence of some gabapentin tablets, a drug used to treat seizures, in a bottle, according to a posting on the FDA website. The batch was manufactured in April 2013 and was set to expire in March 2016.

“Sun Pharma is examining the issue, and would not have anything specific to share beyond the announcement that the US FDA has made," the company said in a statement.

Sun’s recall of the batch of metformin hydrochloride was initiated on Jan. 28, according to the FDA posting.

Generic Lipitor

Ranbaxy recalled 64,626 bottles of its copies of Lipitor after a pharmacist complained of a 20-milligram pill in a sealed 10-milligram bottle, according to an FDA website posting. The recall, its second of atorvastatin in the last 15 months, was initiated on Jan. 16.

Ranbaxy is facing greater US scrutiny after recalling generic Lipitor in November 2012 for possibly containing small particles of glass. Four of Ranbaxy’s Indian facilities have been banned from exporting to the US for failing to meet FDA standards. The company declined to say whether the latest batches to be recalled were made in its plant in New Brunswick, New Jersey.

Ranbaxy hasn’t received any product complaints related to the recalled batches, the company said in an e-mailed statement on March 8. The recall has been conducted at the retail level, the company said.

“Ranbaxy is proactively recalling the lots out of an abundance of caution, keeping the safety of its patients in mind and with the full knowledge of the US FDA," the company said.

Ranbaxy fell 1.6% to 364.60 at the close of Mumbai trading, its biggest decline since 21 February. Sun Pharma fell 2.5%. Bloomberg

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Published: 10 Mar 2014, 07:48 PM IST
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