Lupin subsidiary recalls 5,720 skin treatment tubes in US
The Indian-drug maker Lupin is recalling 5,720 tubes of a skin medicine cream from the US market due to quality issues, according to the United States Food and Drug Administration (USFDA).
As per the latest Enforcement Report by the US health regulator, Lupin Pharmaceuticals Inc, a US-based arm of the Mumbai-based drug maker, is recalling Clobetasol propionate Cream, a steroid to reduce inflammation, redness and itchiness of the skin and prevent further irritation of the skin. The cream is used in the treatment of various skin conditions, such as dermatitis, eczema, and psoriasis.
The affected lot has been manufactured at Lupin's Pithampur plant in Madhya Pradesh and marketed in the US market by Baltimore-based Lupin Pharmaceuticals Inc.
The USFDA noted that the company is recalling the affected lot due to "Subpotent Drug: Low assay result observed during long-term stability testing".
Further, Lupin has initiated the Class III nationwide (US) recall of the affected lot on January 23 this year.
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", USFDA said.
On Monday, at around 9:58 AM, Lupin was trading at Rs735 per share lower by 0.61% on the BSE.