Last Updated on December 31, 2023 by The Health Master
Drug recall
In a recent development reported by the US Food and Drug Administration (USFDA), Alembic Pharmaceuticals and Aurobindo Pharma have undertaken drug recall of certain products in the US market due to manufacturing irregularities.
The actions were taken to ensure product quality and compliance with safety standards.
Drug recall of Tobramycin Ophthalmic Solution by Alembic Pharmaceuticals
Alembic Pharmaceuticals, the renowned pharmaceutical company with a US-based subsidiary, has issued a voluntary recall for 82,400 bottles of Tobramycin Ophthalmic Solution in the American market.
This recall pertains to a specific lot of the product, specifically the 0.3% concentration in a 5ml bottle.
Tobramycin Ophthalmic Solution: A Critical Treatment for Eye Infections
Tobramycin Ophthalmic Solution plays a crucial role in the treatment of bacterial infections of the eye.
However, due to identified “Failed impurities or degradation specifications,” the recall was initiated to address potential quality concerns.
Alembic Pharmaceuticals Inc., based in New Jersey, undertook this Class III voluntary recall on July 27 of the current year.
Understanding Class III Recall
A Class III recall, as defined by the USFDA, is carried out when consumers are not expected to suffer any negative health effects from using or being exposed to a product that has violations.
This classification highlights the precautionary nature of the recall and aims to ensure the well-being of patients.
Aurobindo Pharma’s drug recall of Rufinamide Tablets
In a separate instance, the US arm of Aurobindo Pharma has also initiated recalls for Rufinamide Tablets.
The recall pertains to two different strengths of the medication: 200 mg and USP 400 mg, packaged in 120-count bottles.
Rufinamide Tablets: Addressing Seizure Disorders
Rufinamide Tablets are integral in the treatment of seizure disorders, underscoring their significance in patient care.
The recall was prompted by observed deviations from current good manufacturing practices (cGMP) standards.
Additionally, it’s worth noting that the affected batch of Rufinamide Tablets had been released prior to receiving approval.
Must read: Understanding GMP, cGMP, and WHO-GMP
Insight into Class II Recall
The recall initiated by Aurobindo Pharma USA Inc. for the Rufinamide Tablets falls under the Class II nationwide (US) category.
This recall, instigated on July 21 of this year, indicates a situation where the use of or exposure to a non-compliant product might result in temporary or reversible health consequences.
In summary, Alembic Pharmaceuticals and Aurobindo Pharma’s proactive measures to recall products exemplify their commitment to maintaining high standards of quality and safety in the pharmaceutical industry.
These actions also highlight the diligent oversight of regulatory bodies like the USFDA in safeguarding public health and well-being.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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