Israeli generic drug giant Teva is recalling nearly 39,000 bottles of three drugs manufactured by its Indian supplier Emcure Pharmaceuticals in the U.S. market due to violation of manufacturing norms and GMP deviations.
The recall includes anti-diabetic glyburide and metformin hydrochloride tablets, anti-inflammatory drug indomethacin in different strengths and hypertension drug methyldopa.
According to the FDA, the recalls specifically involve:
• 2,532 bottles of glyburide and metformin hydrochloride tablets for cGMP deviations
• 7,694 bottles of indomethacin 25 mg, and 5,812 bottles of the same drug of 50 mg strength for deviations from CGMP
• 22,820 bottles of methyldopa tablets for violation of manufacturing norms.
Emcure Pharmaceuticals, headquartered in Pune, West India is the 14th largest pharmaceutical company in India. The company has a U.S. manufacturing facility in East Brunswick, NJ.
Read the Economic Times article