Teligent Pharma Recalls Fluocinonide Ointment Due to Impurity
Teligent Pharma is recalling Fluocinonide Ointment USP 0.05% due to out-of-specification impurity 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 documentation or minor issues.
Plain-English summary
Teligent Pharma, Inc. is recalling Fluocinonide Ointment USP 0.05% in 15 gm, 30 gm, and 60 gm tubes. The recall involves 36,790 tubes distributed nationwide in the United States.
The recall was initiated because of failed impurities and degradation tests, specifically out-of-specification results for the Fluocinolone Acetonide impurity. The agency has classified this as a Class III recall, indicating that the product is unlikely to cause adverse health consequences.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The affected lots include various expiration dates ranging from 10/2020 to 4/2022.
The recalled product
- Product
- Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-15, b) 30 gm tube, NDC 52565-0040-30 c) 60 gram tube, NDC 52565-0040-60, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 36,790
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 (20)
- Lot#: a) 12250
- Exp 10/2020
- 15039
- Exp 1/2022
- 15573
- Exp 7/2022
- b) 12250
- 14589
- 14848
- Exp 12/2021
- 15245
- Exp 2/2022
- c) 12241
- 12249
- 14222
- Exp 8/2021
- 15037
- 15246
- 15340
- Exp 3/2022
Distribution
Distributed nationwide across the United States.
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