Glenmark recalls anti-ulcer drug in the US over tablet mix-up
19 Apr 2014
Glenmark Pharmaceuticals Ltd is recalling 2,900 bottles of its anti-ulcer drug ranitidine from the US market after a tablet to treat high blood pressure was found in one of the bottles.
The US Food and Drug Administration (FDA) said that the recalled lot was made by Chennai-based contract manufacturer Shasun Pharmaceuticals Ltd on behalf of Glenmark.
The recall began on 18 March but the FDA posted the recall on Thursday on its website. It said that metoprolol tartrate tablet used to treat high blood pressure was found in ranitidine bottle.
Media reports quoted a Glenmark spokesperson as saying the recall is limited to only one lot of material. Financially, the impact of the recall is very insignificant
The recall comes less than a week after Lupin Ltd, India's fourth-largest pharmaceutical company by market value, recalled thousands of bottles of anti-infection drug Suprax in the US after failing to meet the country's purity test. (See: Lupin recalls Suprax drug from US market after failing to meet US purity test)
The recall is the latest in a series made by Indian drug manufactures in the US market over quality issues.
Ranbaxy Laboratories, which is being acquired by Sun Pharmaceutical Industries, had last year recalled about 480,000 bottles of generic versions of the cholesterol drug Lipitor after glass particles were found in some bottles.
This year, it recalled the over 64,000 bottles of 10-milligram tablets of atorvastatin calcium - the active ingredient in Lipitor due to a potential dosage mix-up due to faulty bottling. (See: Shocking dosage mix-up forces Ranbaxy to recall generic Liptor in US)
Ranbaxy has already been banned from exporting drugs made at any of its four Indian plants to the US because of the FDA concerns about quality (Ranbaxy hit afresh by FDA; all its India-made products banned).
It has also been hauled up by the FDA for falsifying data and test results in approved and pending drug applications, which could lead to defective products.
Sun Pharmaceutical Industries also recalled 2,528 bottles of its generic version of diabetes drug Glumetza in the US this year after some bottles were found to contain drugs meant to treat epilepsy.
The FDA later issued an import alert on Sun Pharmaceutical's Karkhadi plant in Gujarat, which would lead to "detention of import consignments in the US without physical examination of drugs from firms which have not met drug GMPs" (See: And now, USFDA bans imports from Sun Pharma unit).
Worries about quality control in India's $14 billion drug industry have come to the fore in the past year as plants run by Ranbaxy and local rival Wockhardt Ltd have been barred from sending drugs to the US after falling short of the FDA's good manufacturing practices.
Wockhardt recalled five over-the-counter (OTC) medicines in the UK following the British drug regulator's withdrawal of good manufacturing practices (GMP) certificate for its Chikalthana plant in Aurangabad (See: Wockhardt faces fresh strictures from UK drug regulator).
Last month generic drugmaker Dr. Reddy's Laboratories Ltd recalled about 58,656 bottles of heartburn drug lansoprazole in the US over microbial contamination.
