Lupin recalls Suprax drug from US market after failing to meet US purity test

Lupin Ltd, India's fourth-largest pharmaceutical company by market value, is recalling thousands of bottles of anti-infection drug Suprax from the US market after failing to meet US purity test. Lupin's US subsidiary, Baltimore-based Lupin Pharmaceuticals Inc, will recall 9,210 bottles of Suprax made at its Indian plant, the US Food and Drug Administration (FDA) yesterday said on its website. The recalled bottles of Suprax, used to treat bacterial infections of the ear and upper respiratory tract, "did not meet specification in total impurities", the FDA said. This is the second time Lupin is recalling Suprax in the US, after it was forced to recall nearly 65,000 bottles in January last year because of discolouration.


Lupin, which generates 40 per cent of its sales from the US, had also in September 2013 recalled over 53,000 bottles of hypertension drug Quinapril. 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, Aurangabad (Wockhardt faces fresh strictures from UK drug
regulator. This recall came a few months after he British drug regulator issued a precautionary recall of 16 prescription-only medicines made by Wockhardt after it found deficiencies in manufacturing procedures at the its plant in Waluj in Aurangabad.