NEW DELHI, Aug 25: 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 by Glenmark Pharmaceuticals Ltd at its Baddi facility 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 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”.
Lupin’s arm, Lupin Pharmaceuticals Inc, is also recalling 39,216 bottles of Lisinopril and Hydrochlorothiazide tablets USP, 10 mg/12.5 mg, 100 tablet bottle manufactured at its Pithampur facility from the US market, the report said.
The reason for the recall is “presence of foreign substance; product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles,” it added.
The current voluntary class II recall is for the product that was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States, the report said.
The tablets are used for treatment of hypertension.
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”. (agencies)