Clobetasol Propionate Ointment Recalled for Microbial Contamination
Taro Pharmaceuticals is recalling Clobetasol Propionate Ointment USP 0.05% due to the presence of R. Pickettii bacteria in a non-sterile product. The affected lot may have been distributed nationwide through retailers.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. Microbial contamination of a topical pharmaceutical product represents a serious safety concern, even in the absence of reported illnesses.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling Clobetasol Propionate Ointment USP, 0.05%, in 60-gram tubes (NDC 51672-1259-3, Lot# AC13786, expiration date December 2022). The product contains R. Pickettii bacteria contamination in a non-sterile topical pharmaceutical preparation.
The affected lot consisted of 96 tubes distributed to two distributors located in Utah and Louisiana. These distributors could have further distributed the product to retail locations nationwide in the United States.
Clobetasol propionate is a prescription-only corticosteroid ointment used to treat skin conditions. Contamination with R. Pickettii bacteria in a non-sterile topical product poses a safety risk. Consumers or healthcare providers in possession of this lot should stop using it and contact Taro Pharmaceuticals or their healthcare provider for guidance on proper disposal or replacement.
The recalled product
- Product
- CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
- Brand
- CLOBETASOL PROPIONATE
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- microbial-contamination
- bacteria-rickettsia-pickettii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# AC13786
- exp. date DEC 2022
UPCs (1)
- 0351672129422
Distribution
Distributed nationwide across the United States.
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