Teligent Pharma Recalls Clobetasol Propionate Ointment Due to Potency Issues
Teligent Pharma is recalling Clobetasol Propionate Ointment 0.05% because some tubes have superpotent or subpotent assay results.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the Low severity criteria for minor quality deviations.
Plain-English summary
Teligent Pharma, Inc. is recalling 20,160 tubes of Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only (NDC 52565-039-60). The recall is due to superpotent and subpotent, or low and high, assay results.
The affected product is identified by Lot Number 12597 with an expiration date of 12/2020. The product was distributed nationwide.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 20,160
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 Number: 12597
- exp. date 12/2020
Distribution
Distributed nationwide across the United States.
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