The National Agency for Food and Drug Administration and Control has alerted Nigerians on the voluntary recall of a contaminated ointment named Clobetasol Propionate, warning the citizens against using it.
The product, a Clobetasol Propionate Ointment USP, 5%, 60g, was recalled due to microbial contamination, the agency said in a statement.
According to NAFDAC, the product manufactured by Taro Pharmaceuticals is being recalled due to microbial contamination that was reported during routine testing in the United States where it was manufactured.
The agency said they were notified by the US FDA of the recall of the product.
The statement by NAFDAC partly reads, “Clobetasol Propionate Ointment USP, 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
“If contaminated with R. pickettii which is present in the natural environment (soil, water) for healthy individuals with intact skin, it is unlikely to cause any localised or systemic infections.
“However, for individuals who are immunocompromised, or whose skin is not intact (i.e. sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii due to the presence of the corticosteroid component which enhances absorption of the ointment.
“If this bacterium is circulating in the human bloodstream it can cause life-threatening, invasive infections such as sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues.
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“NAFDAC implores importers, distributors, retailers, and consumers to stop the importation, distribution, sale, and use of the affected lot.
“Members of the public in possession of the recalled lots are implored to discontinue the sale or use and hand over the stock they have to the nearest NAFDAC office.
“NAFDAC encourages healthcare professionals, consumers, and patients to report adverse events related to the use of this product to the nearest NAFDAC office, or via pharmacovigilance@nafdac.gov.ng or the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng or med Safety App available for download on android and IOS stores.”
NAFDAC, however, added that “To date, Taro Pharmaceuticals Inc. has not received any reports of adverse events that have been related to this recall.”
