Sun Pharmaceutical Industries is recalling 24,194 pre-filled syringes of Fyremadel (ganirelix acetate) injection, a drug used to treat infertility in women, in the US market due to a manufacturing issue, according to USFDA.
The company is recalling the affected lot due to the presence of particulate matter, the US FDA said. “A piece of glass was found in a prefilled syringe,” it added. The product was manufactured by Sun Pharma and distributed in the US market by Ferring Pharmaceuticals. The company initiated the countrywide (US) recall on April 19 this year, USFDA stated.
Sun Pharmaceutical, 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 company 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.