Glenmark Recalls Montelukast Sodium Tablets Due to Chemical Contamination

Plain-English summary

Glenmark Generics Inc. is recalling Montelukast Sodium Tablets, 10 mg (base), packaged in 30-count and 90-count bottles. The recall involves 591,972 bottles distributed nationwide. The affected products are identified by specific lot codes and expiration dates of 09/14 and 10/14.

The recall was initiated after pharmacists and consumers reported detecting off-odors described as moldy, musty, or fishy. These odors were identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA). The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and pharmacists should stop using the affected products and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product

Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics

Manufacturer

Glenmark Generics Inc., USA

Category

Drug — Prescription Medication

Hazard

• chemical-contamination
• off-odor

Affected units

591,972

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Related recalls