The Mumbai-based pharmaceutical company is recalling 12,336 bottles of buprenorphine sublingual tablets, used to treat opioid use disorder, from the American market, according to the most recent Enforcement Report from the US health department. The contaminated lot (8 mg, 30 count-bottles) is being recalled by Sun Pharmaceutical Industries Inc. due to deviations from current good manufacturing practices (CGMP).
The US Food and Drug Administration (USFDA) has reported that domestic pharmaceutical companies Sun Pharma and Alembic are recalling goods from the US market because of production problems.
The Mumbai-based pharmaceutical company is recalling 12,336 bottles of buprenorphine sublingual tablets, used to treat opioid use disorder, from the American market, according to the most recent Enforcement Report from the US health department.
The affected batch (8 mg, 30 count-bottles) is being recalled by Sun Pharmaceutical Industries Inc, the company’s US-based subsidiary, as a result of deviations from CGMP (Current Good Manufacturing Practice), according to the USFDA.
On May 3 of this year, the business started the CLass II voluntary recall.
Additionally, 7,313 bottles of methylphenidate hydrochloride tablets, a medication used to treat attention deficit hyperactivity disorder, are being recalled by Sun Pharma from the US market.
The USFDA announced that Sun Pharmaceutical Industries Inc. of New Jersey is recalling the lot because of the “presence of foreign substance: metal embedded in a tablet.”
On July 13 of this year, the corporation started the recall, it was added.
Alembic Pharmaceuticals is recalling 2,844 units of Diclofenac Sodium Topical Solution from the American market, according to the US Health Authority.
The drug is used to treat joint arthritic pain and other signs and symptoms.
A “defective delivery system” is the reason Alembic Pharmaceuticals Inc. is recalling the problematic lot, according to the USFDA. On June 22 of this year, the business began the Class II recall.
According to the USFDA, a Class II recall is started when using or being exposed to a product that is in violation may result in short-term or medically treatable adverse health effects or when the likelihood of substantial adverse health effects is remote.
The pharmaceutical sector in India ranks third globally in terms of volume and fourteenth globally in terms of value. In 2021–22, India exported medicines worth Rs. 1,75,040 crore, comprising bulk medications and pharmaceutical intermediates.
The biggest market for pharmaceutical goods worldwide is the US.
Source : Zee Business
