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The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from US FDA that Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level due to the presence of Ralstonia pickettii bacteria which was discovered by the manufacturer through routine testing.
RISK STATEMENT:
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 localized 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 blood stream 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.
To date, Taro Pharmaceuticals Inc. has not received any reports of adverse events that have been related to this recall.
PRODUCT DETAILS:
| Product | NDC | Lot Number | Expiration |
| Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes | # 51672-1259-3 | AC13786 | 12/2022 |
PRODUCT LABEL PHOTO:
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 sale or use, and hand over stock 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, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng or via med Safety App available for download on android and IOS stores.
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
