Industry

Drug recall: Clobetasol Propionate Ointment recalled due to this reason

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

January 10, 2022

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Last Updated on October 6, 2024 by The Health Master

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.

Clobetasol Propionate Ointment USP, 0.05%

This recall ONLY applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product are impacted. Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing.

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.

The one (1) lot being recalled is as follows:

Lot #	Amount	Expiration Date
AC13786	96 units	December 2022

Clobetasol Propionate Ointment USP, 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 USP, 0.05% and the NDC # 51672-1259-3 (see image of container label below).

Click for more on USFDA

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.

These two wholesale distributors may have further distributed this lot to their retail customers for prescription dispensing to patients who were prescribed Clobetasol Propionate Ointment USP, 0.05%, 60 g.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).

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