According to a notification by the US Food and Drug Administration (USFDA), the recall of the 5,400 bottles has been voluntarily initiated by the company through its U.S. based arm Zydus Pharmaceuticals USA Inc.
The company has initiated the recall, which falls under Class II, as “a complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance,” USFDA said.
According to the US health regulator, Class II recall is 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.
The drugs were manufactured by Cadila Healthcare and distributed in the US by Zydus Pharmaceuticals USA Inc.
Comments from the company could not be obtained immediately.
Headquartered in Ahmedabad, Zydus Cadila group has global operations in four continents spread across USA, Europe, Japan, Brazil, South Africa and 25 other emerging markets.
The group’s operations range from active pharmaceutical ingredients (API) to formulations, animal health products and cosmeceuticals.
Cadila Healthcare shares were trading at Rs. 1,330.30 apiece on the BSE, down 1.24 per cent from its previous close. Business Line
