Aurobindo Pharma, Alembic Pharma recall drugs in US over manufacturing lapses
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New Delhi: Alembic Pharmaceuticals and Aurobindo Pharma are recalling different products in the US market due to manufacturing lapses, according to the US Food and Drug Administration (USFDA).
As per the US health regulator's latest Enforcement Report, the US-based subsidiary of Alembic Pharmaceuticals is recalling 82,400 bottles of Tobramycin Ophthalmic Solution in the American market.
Tobramycin Ophthalmic Solution is used to treat bacterial infections of the eye.
New Jersey-based Alembic Pharmaceuticals Inc is recalling the affected lot (0.3 per cent, 5ml bottle) due to "Failed Impurities/Degradation Specifications," USFDA stated.
The company initiated the Class III voluntary recall on July 27 this year.
As per USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences".
Also, the US-based arm of Aurobindo Pharma is recalling 48 bottles of Rufinamide Tablets, (200 mg, packaged in 120-count bottle), due to cGMP (current good manufacturing practice) deviations, USFDA said.
The batch was released prior to approval.
Aurobindo Pharma USA Inc is also recalling 48 bottles of the same medication in different strengths (USP 400 mg) for similar reasons, it added.
The company initiated the Class II nationwide (US) recall on July 21 this year.
Rufinamide tablets are used to treat seizure disorders.
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