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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 96
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
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