Lupin Recalls Clobetasol Propionate Cream Batch in US After Content Uniformity Failure
Mumbai: Lupin Limited is carrying out a voluntary recall of 5,082 tubes of clobetasol propionate cream in the United States after the product failed to meet specified content uniformity requirements.
According to the latest enforcement report of the US Food and Drug Administration (USFDA), the recall was initiated because the affected product did not comply with the required content uniformity specifications. Content uniformity is important to ensure that the active ingredient is consistently present in the intended amount throughout the product.
The recalled batch was manufactured at Lupin’s facility in Pithampur, India. The product involved in the recall is clobetasol propionate cream, a steroid-based topical medication used in the treatment of severe inflammatory skin conditions, including eczema, psoriasis and dermatitis.
The USFDA has classified the recall as a Class II recall. Under this classification, exposure to or use of the affected product may result in temporary or medically reversible adverse health consequences, although the likelihood of serious adverse health effects is considered remote.
The recall is being conducted on a nationwide basis in the United States and is voluntary, following identification of the product’s failure to meet the specified content uniformity standards.
ETPharma reports that the affected batch was manufactured at Lupin’s Pithampur facility in India.
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