Recalls / Class III
Class IIID-0338-2021
Product
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
- Affected lot / code info
- Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022
Why it was recalled
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- 104,784 tubes
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2021-02-02
- FDA classified
- 2021-04-23
- Posted by FDA
- 2021-05-05
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0338-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.