Lupin arm recalls 5,720 tubes of Clobetasol propionate Cream in US over manufacturing issue

Written by Ruchika Sharma Published On 2023-02-06T11:26:46+05:30 | Updated On 6 Feb 2023 11:26 AM IST

Lupin arm recalls 5,720 tubes of Clobetasol propionate Cream in US over manufacturing issue

The USFDA noted that the company is recalling the affected lot due to "Subpotent Drug: Low assay result observed during long-term stability testing".

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.

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".

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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.

Read also: Lupin recalls 16,056 bottles of tuberculosis drug Rifampin in US

Lupin is a transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The company invested 8.7% of its revenue in research and development in FY22.

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Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751