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.
Glenmark Pharmaceuticals Inc, USA is also recalling 9,552 bottles of Naproxen Sodium Tablets (275 mg), a pain relieving medicine, due to "CGMP (Current Good Manufacturing Practice) deviations".
The 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) due to CGMP deviations.
Chlorzoxazone tablets are used for muscle relaxation. 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.
New Jersey-based Aurobindo Pharma USA Inc, a unit of Aurobindo Pharma, is recalling 2,820 bottles of Metoprolol tartrate tablets "due to presence of foreign substance: product complaints received for the presence of metal wire in one tablet".
Metoprolol tartrate tablets are used to treat high blood pressure. The company initiated the Class II recall on September 9 this year.
As per USFDA, a Class-II recall is initiated in a situation "in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".
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