Sun Pharmaceutical Industries is recalling pre-filled syringes of a drug, used to treat infertility in women, in the US market due to a manufacturing issue. The company is recalling 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection. The company is recalling the affected lot due to the presence of particulate matter. A piece of glass was found in a prefilled syringe.
The product was manufactured by Sun Pharma and distributed in the US market by New Jersey-based Ferring Pharmaceuticals Inc. The company initiated the countrywide (US) recall on April 19 this year. The New Jersey-based Sun Pharmaceutical Inc, a unit of the company, has already announced the recall of 16,450 vials of Norepinephrine Bitartrate Injection for ''failed impurities/degradation specifications''.
As per the USFDA, the drugmaker is also voluntarily recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to failed dissolution testing.
Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
