Glenmark Pharmaceuticals pull 2904 bottles of stomach ulcer drug Ranitidine from the US

Move comes after a complaint by a pharmacist.

By The American Bazaar Staff

NEW DELHI: Yet another India-based pharmaceutical company is facing public humiliation in the US, as Glenmark Pharmaceuticals Ltd. announced that it will pull 2,904 bottles of its Ranitidine product from US shelves.

Glenmark announced that the recall was voluntary, and was not initiated by an investigation or order by any outside agency. In a statement relayed to Reuters, Glenmark said that the recall started on March 18, and that “corrective actions have been implemented and the recall is limited to only one lot of material.” The company also said that, from a financial standpoint, the effect of the recall would be “very insignificant.”

Ranitidine is a stomach ulcer drug; according to the company, there is nothing wrong with the drug itself, and the recall was started because of a packaging error. The US Food and Drug Administration, on its website, said that a mistakenly placed drug was found in a bottle of Ranitidine, causing the company to recall several bottles for reasons of quality assurance.

“[The] recall is due to a pharmacist’s complaint of a foreign material, identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg,” said the FDA.

The recall has been classified as Class II, meaning that it is a situation in which “use of or exposure to a violative [sic] product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Glenmark said that the recall was limited only to a single lot of the pills, although the company did not disclose where the more than 2,900 bottles would specifically be pulled from, nor where the one bottle with the abnormal medication was actually found.

Glenmark is based in Mumbai, and operates in around 95 countries around the world through its various subsidiaries. Its manufacturing plants are located in Maharashtra, Goa, Himachal Pradesh, and Gujarat. Glenmark’s pharmaceutical products typically specialize in the treatment of Dermatology, Internal Medicine, Pediatrics, Gynecology, ENT and Diabetes.