Sun Pharma recalls over 24K prefilled syringes of generic medication in the US

Drug major 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, according to the US health regulator. In its latest Enforcement Report, the US Food and Drug Administration (USFDA) noted that the Mumbai-based drug major 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, the USFDA 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 New Jersey-based Ferring Pharmaceuticals Inc. The company initiated the countrywide (US) recall on April 19 this year, USFDA stated.

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.

The Indian pharmaceutical industry is the world’s third-largest by volume and 14th-largest in terms of value. India exported pharmaceuticals worth Rs 1,75,040 crore in the financial year 2021-22, including bulk drugs/ drug intermediates.

The US is the world’s largest market for pharmaceutical products.