FDA MedWatch - Clobetasol Propionate Ointment USP, 0.05% by Taro Pharmaceuticals:

U.S. Food and Drug Administration sent this bulletin at 12/31/2021 09:05 AM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Clobetasol Propionate Ointment USP, 0.05%, 60 g Tubes, Lot AC13786 by Taro Pharmaceuticals: Recall - Due to Microbial Contamination

AUDIENCE: Patient, Health Professional, Pharmacy, Dermatology

ISSUE: Taro Pharmaceuticals is recalling one (1) lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing. This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product are impacted.

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 (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 sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues.

To date, Taro has not received any adverse event reports related to this lot.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Clobetasol Propionate Ointment USP, 0.05% is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

RECOMMENDATIONS:

Retail customers that have any quantities of Lot AC13786 which is being recalled, should stop distribution and return any unsold units to their wholesaler.
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.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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