Taro Pharmaceuticals has issued a voluntary recall of 1 lot of Clobetasol Propionate Ointment USP, 0.05%, 60g tubes to the consumer level due to the presence of Ralstonia pickettii (R. pickettii) bacteria discovered by the manufacturer through routine testing.
Clobetasol Propionate Ointment is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. The recalled lot of Clobetasol Propionate Ointment USP, 0.05%, 60g tubes; NDC # 51672-1259-3; Lot # AC13786; expiration date December 2022, was distributed to 2 wholesale distributors between November 16, 2021 and December 6, 2021 in the United States.
According to the Company, R. pickettii is unlikely to cause any localized or systemic infections in healthy individuals. However, use of recalled product in individuals who are immunocompromised or whose skin is not intact may potentially lead to serious systemic infections, as the corticosteroid component enhances absorption of the ointment. To date, the Company has not received reports of adverse events related to this recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
For more information regarding this recall contact Taro Pharmaceuticals at (866) 923-4914 or by email at [email protected].
Taro Pharmaceuticals USA issues voluntary nationwide recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g tubes, lot AC13786 due to microbial contamination. News release. US Food and Drug Administration. December 30, 2021. Accessed January 4, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-issues-voluntary-nationwide-recall-clobetasol-propionate-ointment-usp-005.