Dr Reddy’s, Glenmark recall drugs from US market on odour complaints

Amrita Nair Ghaswalla Mumbai | Updated on March 15, 2013 Published on March 15, 2013

Dr Reddy’s Laboratories has recalled its anti-depression drug Citalopram from the US market, following complaints of a strong odour. Mumbai-based Glenmark Pharmaceuticals too recalled its allergy and asthma drug in February, after reports that some batches of bottle containing the Montelukast sodium tablets were emitting an odour.

Dr Reddy’s generates more than 50 per cent of its revenues from the US business, where it sells a variety of products, including Para IV filings targeting patented drugs and various low-competition products. Glenmark derives over a third of its revenues from the US market, with a portfolio of more than 80 generic products.

No financial impact

Both drug companies have voluntarily recalled the drugs from the US market as a precaution. A Dr Reddy’s official said the recall is being done with the knowledge of the US Food and Drug Administration (USFDA) and there would be no material financial impact from it.

The market for unipolar depression remedies in the US is around $11.6 billion. The Citalopram tablets for depression are manufactured at Dr Reddy’s Bachupalli plant. In 2004, the company had obtained USFDA approval for the drug, which is the generic equivalent of Forest Laboratories’ Celexa.

In the case of Glenmark, a retail (pharmacy) level product recall involving certain lots of Glenmark’s allergy and asthma drug was conducted by Glenmark Generics based on several complaints from pharmacists and consumers.

Trace chemicals

Reacting to complaints of “musty or fishy odours of preservative chemicals,” Glenmark too voluntarily withdrew the drug. An official said the company continues to ship unaffected batches of the product in alternative bottles.

The USFDA approved Glenmark’s generic version of the drug in 2012. The company said, after initial investigation, that the source for the musty odour was identified as the presence of trace levels of certain chemicals Tribromoanisole and Trichloroanisole in the plastic bottles.

An official said the company did not expect the chemicals to pose a health hazard to patients.

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Published on March 15, 2013
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