Glenmark, Aurobindo recall multiple products in US
Due to various reasons like deviation from standard manufacturing protocols and presence of foreign substance in one of the affected lots
image for illustrative purpose
New Delhi: Glenmark Pharmaceuticals and Aurobindo Pharma are recalling multiple products in the US market due to various reasons like deviation from standard manufacturing protocols and presence of foreign substance in one of the affected lots.
As per the latest enforcement report issued by the US Food and Drug Administration (USFDA), Glenmark's US-based unit is recalling various products in the US market. The company is recalling 28,658 cartons of Fulvestrant injection (250 mg/5 ml), a medicine used to treat breast cancer, due to "lack of assurance of sterility", the US health regulator noted in the report.
The company is also recalling 9,552 bottles of Naproxen Sodium Tablets (275 mg), a pain-relieving medicine, due to "CGMP (Current Good Manufacturing Practice) deviations". It is company is also recalling around 31,500 bottles of the product in 550 mg strength. Besides, Glenmark is recalling 6,552 bottles of Chlorzoxazone tablets (in strengths of USP 375 mg and 750 mg) which are used for muscle relaxation, due to CGMP deviations.
The USFDA stated that the company is also recalling around 2.34 lakh bottles (multiple strengths) of Zonisamide capsules, an anti-epilepsy drug, due to CGMP deviations. The drug firm is also recalling close to 11,000 units of Arformoterol Tartrate Inhalation Solution, indicated for the treatment of chronic obstructive pulmonary disease, for "lack of assurance of sterility".
Glenmark Pharmaceuticals Inc, USA, initiated the Class II recall of all the affected lots on August 27, 2021.
