)
Montelukast Sodium tablets are Glenmark's generic version of Singulair by Merck & Co. Inc., indicated for prophylactic treatment of chronic asthma.
A notification issued by US FDA said that Glenmark was withdrawing from the market as many as 591,972 bottles of Montelukast Sodium tablets of both 30 and 90-count on complaints of off-odour (an odour that is not natural or up to set standard owing to deterioration or contamination).
"The recall has been initiated on multiple complaints received from pharmacists and consumers saying they detected an off-odour, described as moldy, musty or fishy in nature, which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA)", said an alert issued by the US FDA.
When contacted a Glenmark official said the recall was voluntary from the drug-maker's side and an inquiry had already been initiated on February 13.
He said the financial implication of the decision was negligible.
Glenmark Generics received final Abbreviated New Drug Approval (ANDA) for Montelukast Sodium Tablets (10mg) in August, 2012.
"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).
The presence of TBA and TCA has been observed in HDPE bottles supplied by one of our multiple HDPE bottle suppliers used in the packaging of our Montelukast Sodium Tablets. These compounds are often used as a preservative in wood-derived packaging storage materials, Glenmark had said last month.
The levels at which these compounds occur in the product, while capable of producing detectable off-odours, are not expected to pose a health hazard to the patient, it added.
"We have determined that all of Glenmark's Montelukast Sodium Tablets continue to be safe and effective, and there is no reason to stop taking this medication", the statement issued by Glenmark had said.
This recall is limited to material stored by wholesalers and in stock in pharmacies from the lot numbers and bottles identified above only and all other lots and bottles in use are unaffected and pharmacies may continue to dispense.
Glenmark continues to ship unaffected product in alternative bottles, the release said.
