Drug 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
D-0339-2021
Product summary
- Event
- Event 87266
- Status
- Terminated
- Classification
- Class III
- Quantity
- 79,416 tubes
- Official record key
drug-enforcement:D-0339-2021
Official wording
Reason: Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Code information: Lot #: 14297, Exp 9/2021; 15757, Exp 6/2022; 15840, Exp 7/2022; 15970, Exp 9/2022; 15993, Exp 9/2022
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.