Drugmaker Glenmark Pharmaceuticals has initiated a nationwide voluntary recall of over 31,000 tubes of anti-fungal Clotrimazole and Betamethasone Dipropionate cream from the US market due to “temperature abuse” of the drugs.
The recall has been initiated by its US arm Glenmark Pharmaceuticals Inc, USA.
According to the latest Enforcement Report by the US Food and Drug Administration (FDA), the company is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate cream USP, 1%/0.05% in 15 gram tubes with an expiry of March 2020. It has been manufactured at the company’s Baddi facility in Himachal Pradesh.
The ongoing voluntary class III recall is due to complaints received of “liquidy texture”, US FDA said.
Clotrimazole and Betamethasone Dipropionate cream is used for treatment of fungal infections of the feet, genitals, inner thighs and buttocks, arms and legs and other body parts.
As per USFDA, 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”.