Drugmaker Lupin is recalling 5,720 tubes of a cream used in the treatment of various skin conditions, such as dermatitis, eczema and psoriasis, from the U.S. market due to a manufacturing issue, according to the U.S. Food and Drug Administration.
As per the latest Enforcement Report by the U.S. health regulator, Lupin Pharmaceuticals Inc., a U.S.-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 affected lot has been manufactured at the company’s Pithampur plant in Madhya Pradesh and marketed in the U.S. 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”.
The company initiated the Class III nationwide (U.S.) recall of the affected lot on January 23 this year.
As per the 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”.
The U.S. generic drug market was estimated to be about $115.2 billion in 2019. It is the largest market for pharmaceutical products.
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