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 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”.
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.