Indian company, Sun Pharmaceutical Industries, recalled 24,194 syringes of an infertility drug from the U.S. market after a recent report from the US Food and Drug Administration (USFDA) raised a manufacturing issue.
According to the California Board of Pharmacy, the syringes didn’t pass the required quality checks of the USFDA, which filed a complaint on observing glass particles in the prefilled syringes of Fyremadel (ganirelix acetate) injection. Upon investigation, the identifiable cause was found to be the malalignment of the syringe in the centring frame before it was filled.
The product in question was distributed by New Jersey-based Ferring Pharmaceuticals in the U.S. The company has been in business with India-based Sun Pharma in the past and this isn’t the first recall incident. Seven lots of the Ganirelix Acetate injection were distributed in the country between June 2019 and June 2020 with March 2021 as its expiry date was recalled at the retail level, according to the board of pharmacy notice.
Aside from this, Sun Pharma voluntarily recalled 34,000 bottles of Diltiazem Hydrochloride, a generic drug used to treat high blood pressure, from the U.S. market at the beginning of this year. The reason for the recall was failed impurity specification during the stability test at the FDA laboratory. The drug also failed the dissolution test.
One of Sun Pharma’s manufacturing facilities has run into trouble for violations by the USFDA in the past. In Dec last, the health regulator issued a warning letter to the company after inspecting its facility in Halol, Gujarat over a period of 13 days.
In the letter, the USFDA said that the firm failed to follow appropriate procedures designed to prevent microbiological contamination of drug products to ensure that they were sterile and aseptic. The full report can be accessed here. The U.S. is the largest importer of pharmaceutical products from India. According to the Nov. 2022 report India’s pharma exports to the U.S. during the 2021-22 period were estimated at US$7,101 million.
India’s drug and pharmaceutical export during 2021-22 was estimated at $24.62 billion. India is the largest provider of generic medicine the world over, with around 60% contribution to global vaccines. Being the largest supplier of low-cost vaccines around the world, the country is also known as the “Pharmacy of the World.”
