IGMPI India



Teva recalls around 39,000 bottles of drug from US market

Teva Pharmaceuticals is recalling around 39,000 bottles of the drugs manufactured by its Indian supplier Emcure Pharmaceuticals in the US market due to violation of manufacturing norms. The recall includes anti-diabetic glyburide and metformin hydrochloride tablets, anti-inflammatory drug indomethacin in different strengths and hypertension drug methyldopa.

Teva Pharmaceutical Industries Ltd. is an international pharmaceutical company headquartered in Petah Tikva, Israel. It specializes in generic and proprietary pharmaceuticals and active pharmaceutical ingredients. It is the largest generic drug manufacturer in the world and one of the 15 largest pharmaceutical companies worldwide. The company has also issued a recall in April for more than 1 million bottles of generics of Eli Lilly's top-selling blockbuster Cymbalta. All of those drugs were manufactured at a Teva plant in Israel and were being recalled because of a customer complaint about capsule breakage.

According to FDA, the company is recalling 22,820 bottles of methlodopa tablets indicated for low blood pressure, 13,506 bottles of indomethacin capsules (25 mg and 50 mg strength) and 2,532 bottles of glyburide and metformin hydrochloride tablets. All of these were manufactured at Emcure’s plant in Hinjawadi in Pune, India. The drugs are being recalled because the laboratory testing was not followed in accordance with GMP requirements. All the recalls fall under Class II, in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or there is remote probability of serious adverse health consequences.