Drugmakers Glenmark and Aurobindo Recall Products in US, Health News, ET HealthWorld

Glenmark Pharmaceuticals and Aurobindo Pharma are recalling several products from the US market for various reasons, such as a deviation from standard manufacturing protocols and the presence of foreign substances in one of the affected lots. According to the latest application report released by the United States Food and Drug Administration (USFDA), the US unit of Glenmark is recalling various products from the US market.

The company is recalling 28,658 cartons of injectable Fulvestrant (250 mg / 5 ml), a drug 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 vials of Naproxen Sodium (275 mg) pain reliever tablets due to “Current Good Manufacturing Practice (CGMP) deviations”.

The company is also recalling approximately 31,500 bottles of the 550 mg product.

In addition, Glenmark is recalling 6,552 vials of Chlorzoxazone Tablets (USP 375 mg and 750 mg Concentrates) due to CGMP discrepancies.

Chlorzoxazone tablets are used for muscle relaxation. The USFDA said the company is also recalling about 2.34 lakh (multiple strength) bottles of Zonisamide, an anti-epileptic drug, due to deviations from CGMP.

The pharmaceutical company is also recalling nearly 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 affected lots on August 27, 2021.

New Jersey-based Aurobindo Pharma USA Inc, a unit of Aurobindo Pharma, recalls 2,820 bottles of metoprolol tartrate tablets “due to presence of foreign substance: product complaints received for presence of thread metallic in a tablet “.

Metoprolol tartrate tablets are used to treat high blood pressure. The company launched the Class II recall on September 9 of this year.

According to the USFDA, a Class II recall is initiated in a situation “in which the use of or exposure to a nonconforming product may result in temporary or medically reversible adverse health consequences or when the likelihood of serious adverse consequences for health is low “.