Last Updated on October 10, 2024 by The Health Master
Mumbai: Drug maker 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 US market due to a manufacturing issue, according to the US Food and Drug Administration (USFDA).
According to the most recent Enforcement Report by the US health regulator, the Mumbai-based drug manufacturer, Lupin Pharmaceuticals Inc., is recalling Clobetasol propionate Cream, a steroid used to treat skin irritation by reducing inflammation, redness, and itching.
The affected lot has been manufactured at the company’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.”
The company initiated the Class III nationwide (US) 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.”
In 2019, the US generic drug market is expected to be worth approximately USD 115.2 billion. It is the largest market for pharmaceutical products.
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