Last Updated on December 31, 2023 by The Health Master
Drug recall
In a recent development, domestic pharmaceutical companies, Sun Pharma and Alembic, are undertaking product recalls in the US market due to manufacturing concerns.
The US Food and Drug Administration (USFDA) has reported these recalls in its latest Enforcement Report.
Sun Pharma, based in Mumbai, is recalling 12,336 bottles of Buprenorphine Sublingual tablets, used for treating opioid use disorder, while also recalling 7,313 bottles of Methylphenidate Hydrochloride tablets, used to address attention deficit hyperactivity disorder.
On the other hand, Alembic Pharmaceuticals is recalling 2,844 units of Diclofenac Sodium Topical Solution, which is used to alleviate pain and other symptoms of arthritis of the joints.
Sun Pharma’s Recalls
Buprenorphine Sublingual Tablets Recall
Sun Pharma’s US-based arm is recalling 12,336 bottles of Buprenorphine Sublingual tablets in the American market.
The affected lot consists of 8 mg, 30 count-bottles.
Reason for Recall: The recall is attributed to Current Good Manufacturing Practice (CGMP) deviations, as indicated by the USFDA.
Initiation of Recall: Sun Pharma initiated this voluntary Class II recall on May 3 this year.
Methylphenidate Hydrochloride Tablets Recall
Sun Pharma is also recalling 7,313 bottles of Methylphenidate Hydrochloride tablets in the US market.
Reason for Recall: The recall is due to the “presence of foreign substance: metal embedded in a tablet“, as stated by the USFDA.
Initiation of Recall: The recall process was initiated by the company on July 13 this year.
Alembic’s Recall
Diclofenac Sodium Topical Solution Recall
Alembic Pharmaceuticals is recalling 2,844 units of Diclofenac Sodium Topical Solution in the American market.
The medication is commonly used to treat pain and other symptoms of arthritis of the joints.
Reason for Recall: The recall is attributed to a “defective delivery system“, as reported by the USFDA.
Initiation of Recall: Alembic Pharmaceuticals Inc initiated this Class II recall on June 22 this year.
Understanding Class II Recall
As defined by the USFDA, a Class II recall is initiated when there is a possibility that the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
Pharmaceutical Industry Insights
The pharmaceutical industry in India holds a prominent position on the global stage.
It ranks as the world’s third-largest in terms of volume and 14th-largest concerning value.
India’s pharmaceutical exports reached a significant value of Rs 1,75,040 crore in 2021-22, which includes bulk drugs/drug intermediates.
The United States, being the largest market for pharmaceutical products worldwide, plays a crucial role in the industry’s global landscape.
Conclusion
Sun Pharma and Alembic’s voluntary recalls in the US market emphasize the importance of maintaining stringent manufacturing practices to ensure product safety and efficacy.
As these recalls address potential deviations and defects, the focus on quality control and adherence to regulations remains paramount in the pharmaceutical industry to safeguard patient health and maintain consumer confidence.
Disclaimer: This article contains information derived from ET Healthworld. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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