Aurobindo Pharma, Alembic Pharma recall drugs in US over manufacturing lapses
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...
Login or Register to read the full article
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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd