The voluntary class III recall is due to temperature abuse
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 (US FDA), Glenmark Pharmaceuticals 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 US, US FDA 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 US FDA, a class III recall is initiated in a situation “in which use of or exposure to a violative product is not likely to cause adverse health consequences”.