New DelhiDrugmaker
She-wolf is recalling 5,720 tubes of cream used in the treatment of various skin conditions, such as dermatitis, eczema and psoriasis, from the US market due to a manufacturing problem, according to the US Food and Drug Administration. According to the latest enforcement report from the US health regulator,
Lupine Pharmaceuticals Inc, a US-based branch of the Mumbai-based drug maker recalls Clobetasol propionate cream, a steroid to reduce inflammation, redness and itching of the skin and prevent further irritation of the skin.
The affected lot was manufactured at the company’s Pithampur plant in
Madhya Pradesh and marketed in the US market by Lupine Pharmaceuticals Inc., based in Baltimore.
The US FDA noted that the company is recalling the affected batch 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 batch on January 23 of this year.
According to the USFDA, a Class III recall is initiated in a “situation where use of or exposure to a conflicting product is not likely to result in adverse health effects.”
The generic drug market in the US was estimated to be worth approximately $115.2 billion in 2019. It is the largest market for pharmaceutical products.
