On 4 February 2023, Lupin announced the recall of Clobetasol propionate cream over quality issues. As per the USFDA [1], the pharma major recalled 5,720 tubes of Clobetasol propionate cream from the U.S. market due to its poor quality. This cream is indicated for use in various skin conditions like dermatitis, eczema, and psoriasis.
The recalled tubes were manufactured in Lupin’s Pithampur plant in Madhya Pradesh. The USFDA’s formal reason for this recall was cited as “sub-potent drug: Low assay result observed in long-term stability testing.”
Lupin issues nationwide recall of Clobetasol propionate cream from the U.S. market over quality issues.
Outlook India – 4 February 2023
This recall of Clobetasol propionate cream is classified as a Class III recall by the drug major and was initiated on 23 January 2023. It is generally initiated when the use or exposure to the drug or violative product is not likely to cause any adverse health consequences. (recall of Clobetasol propionate cream)
Learn more about the key terms:
USFDA
The United States Food and Drug Administration (USFDA) is a federal agency of the United States Department of Health and Human Services. The USFDA protects the public health by ensuring the efficacy, safety, and security of medicines, biological products, and medical devices. It also ensures the safety of the food supply, cosmetics, and products that emit radiation. The US FDA is also responsible for speeding up innovations that make medicines and foods more effective and safer.
class III recall
A class III recall is the most severe type of recall issued by the U.S. Food and Drug Administration (FDA). It is used when a product poses a potential hazard to people’s health, but the risk is not likely to cause serious adverse health consequences. Examples of products that could be recalled due to a class III recall include food, drugs, medical devices, and dietary supplements.
Clobetasol propionate
Clobetasol propionate is a prescription topical corticosteroid used to treat inflammatory skin conditions such as eczema, psoriasis, and dermatitis. It is a potent corticosteroid and is available as a foam, solution, lotion, cream, and scalp solution. Clobetasol propionate works by decreasing inflammation and suppressing an overactive immune system. Read about Hydrocortisone-Antifungal Drugs- Indications, Dosage, Contraindications, ADRs