Alembic, Sun Pharma recall Ganirelix Acetate, Metformin HCL respectively in US
New Delhi: Leading drug makers Sun Pharma and Alembic Pharmaceuticals are recalling different products in the US, the world's largest market for medicines.
As per the latest Enforcement Report by the US Food and Drug Administration (USFDA), US-based unit of Sun Pharma is recalling 91,211 pre-filled syringes of Ganirelix Acetate injection due to "failed impurities/degradation specifications".
The affected lot has been manufactured at Sun Pharma's Halol plant in Gujarat and distributed in the US by Ferring Pharmaceuticals Inc, the report stated.
The drug major initiated the recall on March 15 this year and the USFDA has classified it as Class II action, which is undertaken 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".
Ganirelix Acetate Injection is used in assisted reproduction to control ovulation.
Princeton (New Jersey) based Sun Pharmaceutical Industries Inc is also recalling 2,520 bottles of diabetes drug, Metformin HCl Extended-Release tablets, in the US market.
As per the USFDA, the drug firm is recalling the affected lot, which is also manufactured in a Gujarat-based plant, for "failed moisture limits: Out of specification for water content".
The company initiated the recall on March 25 and the US health regulator has placed the action under Class III.
As per the 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".
Similarly, Alembic Pharmaceuticals is recalling 12,288 bottles of Telmisartan Tablets (USP 20 mg, 30-count bottles) in the US market. As per the USFDA, the drug firm is recalling the product for "label mix up".
The affected lot has been produced at the company's Panelav based plant in Gujarat and then shipped to Bridgewater (New Jersey) based Alembic Pharmaceuticals, Inc.
Telmisartan Tablets are mainly indicated for the treatment of hypertension.
According to industry estimates, the US generic drug market was estimated to be around USD 115.2 billion in 2019.
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