Teligent Pharma Recalls Betamethasone Dipropionate Ointment Due to Impurity Failures
Teligent Pharma is recalling 79,416 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented) because the product failed impurity specifications.
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 recall as Class III, which indicates a violation of labeling or manufacturing standards that is not likely to cause adverse health consequences.
Plain-English summary
Teligent Pharma, Inc. is recalling 79,416 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes. The product is identified by NDC 52565-019-51 and was distributed nationwide in the United States.
The recall was initiated because the product failed impurities and degradation specifications, specifically showing out-of-specification results for the known impurity Betamethasone 17-propionate. The affected lots include 14297 (Exp 9/2021), 15757 (Exp 6/2022), 15840 (Exp 7/2022), 15970 (Exp 9/2022), and 15993 (Exp 9/2022).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be discontinued and returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Corticosteroid
- Hazard
- Affected units
- 79,416
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 (9)
- Lot #: 14297
- Exp 9/2021
- 15757
- Exp 6/2022
- 15840
- Exp 7/2022
- 15970
- Exp 9/2022
- 15993
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Teligent Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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