Lupin’s subsidiary recalls over 5,500 skin treatment ointments from US amid manufacturing issue

Lupin arm recalls cream tubes: Lupin is recalling 5,720 tubes of a cream used in the treatment of various skin conditions from the US market. The drugmaker is recalling these tube creams due to a manufacturing issue, according to the US Food and Drug Administration.

These tube creams are for skin conditions like dermatitis, eczema and psoriasis

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, as per the latest Enforcement Report by the US health regulator.

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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, said PTI.

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, PTI said.
 
(With PTI inputs)