Alembic, Sun Pharma recall Ganirelix Acetate, Metformin HCL respectively in US
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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.
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