Aurobindo Pharma, Alembic Pharma recall drugs in US over manufacturing lapses

Published On 2023-08-21 11:28 GMT | Update On 2023-08-21 11:32 GMT

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.

Read also: Alembic Pharma, Sun Pharma recall drugs in US over manufacturing issues

Article Source : PTI

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Comments Policy

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 .

Aurobindo Pharma, Alembic Pharma recall drugs in US over manufacturing lapses

Similar News

Merck receives positive EU CHMP opinion for Enflonsia for RSV in infants

Chennai Pharma Firm Under ED Net in Rs 637 Crore Bank Fraud Case

Biocon Gets CDSCO Panel Nod to Import Aflibercept Injection for Eye Disorders, Phase IV Trial Mandated

94 Drug, Medical Product Batches Fail CDSCO Quality Tests in August

Roche subcutaneous formulation of Lunsumio recommended by CHMP for EU nod for follicular lymphoma

Bayer new drug application for gadoquatrane accepted for review in China

JnJ gets positive CHMP opinion of nipocalimab for antibody-positive patients living with generalised myasthenia gravis

Allahabad HC Grants Relief to Pharma Firm Against Tax Notices