The Indian pharma major Lupin Limited is recalling 5,720 tubes of Clobetasol propionate Cream from the US market over quality concerns, according to the US Food and Drug Administration (USFDA).
The decision to recall comes after the USFDA finding: "Subpotent Drug: Low assay result observed during long-term stability testing". The cream treats skin conditions such as dermatitis, eczema, and psoriasis.
A Class III recall was initiated on January 23, 2023. The USFDA 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".
What leads to a drug recall?
A drug recall can occur when a prescription or OTC medication is removed from the market because it is either defective or potentially harmful. Sometimes, the drug makers discover a problem with their drug and recall it themselves. At other times, the FDA can request the drug maker to recall the medication after receiving feedback from the public.
