Pharma major Glenmark is recalling over 31,000 tubes of anti-fungal Clotrimazole and Betamethasone Dipropionate cream from the US market, as per a report by the American health regulator. The company’s US-based arm is recalling the lots.
According to the latest Enforcement Report by the US Food and Drug Administration (USFDA), Glenmark Pharmaceuticals Inc USA is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate cream USP, 1 per cent/0.05 per cent, 15 gram tubes, manufactured in Himachal Pradesh.
The ongoing voluntary class III recall is on account of “Temperature Abuse: complaints received of liquidy texture,” it added.
The recall is a nationwide within the United States, the USFDA said.
Clotrimazole and Betamethasone Dipropionate cream is used on the skin to treat fungal infections of the feet, genitals, inner thighs and buttocks, arms and legs and other body parts.
As per USFDA, a class II recall is initiated in 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”.