New Delhi: Israeli drug-maker Teva is recalling nearly 39,000 bottles of three 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.
According to information available on US Food and Drug Administration's (USFDA) website, Teva is recalling 2,532 bottles of glyburide and metformin hydrochloride tablets for deviations from Current Good Manufacturing Practice (CGMP). The nationwide recall of the four lots was initiated by Teva on March 24.
The company is also recalling 7,694 bottles of anti- inflammatory drug indomethacin 25 mg, produced by Emcure Pharma, for non-adherence to CGMP. Besides, the company is recalling 5,812 bottles of the same drug of 50 mg strength for deviations from CGMP. Further, the company is recalling 22,820 bottles of methyldopa tablets, indicated for low blood pressure, in the US for violation of manufacturing norms.
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. Comments from Emcure Pharmaceuticals could not be obtained immediately.
