Glenmark slips 2% on recall of anti-asthma drug in US

Moneycontrol Bureau

Glenmark Pharma shares declined more than 2 percent on Tuesday morning as the company's recall of its anti-asthma drug from the US market got the street nervous.

Glenmark's US Generics arm said that it was withdrawing multiple lots of Montelukast Sodium tablets of 10mg strength on complaints of off-odour.

The Montelukast Sodium tablets are a copy of Merck and Co's Singulair tablets and are used in the treatment of chronic asthma and prophylaxis.

"The recall has been initiated based on multiple complaints received from a number of pharmacists and consumers. They have reported that they detect an off-odour, described as moldy, musty or fishy in nature," Glenmark Generics said.

It said that after initial investigation, the source for the moldy/musty odour has been identified as the presence of trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA) (often used as a preservative in wood-derived packaging storage materials) in HDPE bottles supplied by one of its multiple bottle suppliers used in the packaging of the tablets.

The recall of the drug launched last year was voluntary, it said.

Glenmark further clarified that levels at which these compounds were found in the product might have produced off-odour, but were not expected to pose a health hazard to patients.

The tablets continue to be safe and effective medication, it added.

At 9:45 hrs, Glenmark shares were down almost 2 percent at Rs 490.55 on NSE.