Domestic drug makers Sun Pharma and Alembic are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA).
As per the US health regulator’s latest Enforcement Report, the Mumbai-based drug major is recalling 12,336 bottles of Buprenorphine Sublingual tablets, used for treating opioid use disorder, in the American market.
Sun Pharmaceutical Industries Inc, the US-based arm of the company, is recalling the affected lot (8 mg, 30 count-bottles) due to CGMP (Current Good Manufacturing Practice) deviations, the USFDA stated.
The company initiated the CLass II voluntary recall on May 3 this year.
Sun Pharma is also recalling 7,313 bottles of Methylphenidate Hydrochloride tablets, used to treat attention deficit hyperactivity disorder, in the US market.
New Jersey-based Sun Pharmaceutical Industries Inc is recalling the lot due to the “presence of foreign substance: metal embedded in a tablet”, the USFDA stated.
The company initiated the recall on July 13 this year, it added.
The US Health regulator stated that Alembic Pharmaceuticals is recalling 2,844 units of Diclofenac Sodium Topical Solution in the American market.
The medication is used to treat pain and other symptoms of arthritis of the joints.
Alembic Pharmaceuticals Inc is recalling the affected lot due to “defective delivery system”, USFDA said. The company initiated the Class II recall on June 22 this year.
As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The Indian pharmaceutical industry is the world’s third-largest by volume and 14th-largest in terms of value. India exported pharmaceuticals worth Rs 1,75,040 crore in 2021-22, including bulk drugs/ drug intermediates.
The US is the world’s largest market for pharmaceutical products.
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