Alembic, Aurobindo to recall products in US market owing to manufacturing lapses

22 Aug 2023 , 10:36 AM

According to the US Food and Drug Administration (USFDA), Alembic Pharmaceuticals and Aurobindo Pharma are recalling various products in the US market due to production flaws.

According to the most recent Enforcement Report from the US Food and Drug Administration, Alembic Pharmaceuticals’ US-based business is recalling 82,400 bottles of Tobramycin Ophthalmic Solution from the American market.

Tobramycin Ophthalmic Solution is used for the treatment of bacterial infections of the eye.

Alembic Pharmaceuticals Inc, situated in New Jersey, is recalling the affected lot (0.3%, 5ml bottle) due to ‘Failed Impurities/Degradation Specifications,’ according to the USFDA.

On July 27, this year, the business began the Class III voluntary recall.

Aurobindo Pharma’s US arm is also recalling 48 bottles of Rufinamide Tablets (200 mg, packaged in a 120-count bottle) due to cGMP (current good manufacturing procedure) variations, stated the USFDA. On July 21, this year, the business began the Class II nationwide (US) recall.

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