Drug Safety Alerts

Clobetasol Propionate Ointment 0.05% Consumer-Level Recall

12/30/2021

On December 30, 2021, the United States Food and Drug Administration (FDA) published a notice regarding a consumer-level recall of one lot of Clobetasol Propionate Ointment, 0.05% NDC #51672-1259-03 manufactured by Taro Pharmaceuticals USA. This recall was issued due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

This recall affects lot AC13786 exp. 12/2022.

According to Taro, R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised, or whose skin is not intact (ie. 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. Taro advises that if this bacterium is circulating in the human blood stream it can cause life-threatening, invasive infections such sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues. Taro reports that as of the date of recall, it has not received any adverse event reports related to this lot.

Clobetasol Propionate Ointment, 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses and is packaged in 60 g aluminum tubes with polypropylene puncture-tip caps. Each 60 g tube is labeled to indicate the name of the product, Clobetasol Propionate Ointment, 0.05% and the NDC #51672-1259-03. The lot number and expiration date are displayed on the bottom of each tube and the end flap of the product carton.

Ninety-six (96) units of Lot AC13786 were distributed to two wholesale distributors in the U.S. market between November 16 and December 6, 2021. Taro has notified the affected distributors by phone, e-mail, and letters via U.S. Mail and is arranging for return of any containers of Clobetasol Propionate Ointment, 0.05%, 60 g, lot AC13786 exp. 12/2022.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information, call Taro Pharmaceuticals USA at 1-866-923-4914, Monday through Friday between 7:00 AM and 7:00 PM (CST) or by e-mail at TaroPVUS@taro.com. You may also call the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.