Drug 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
D-0338-2021
Product summary
- Event
- Event 87266
- Status
- Terminated
- Classification
- Class III
- Quantity
- 104,784 tubes
- Official record key
drug-enforcement:D-0338-2021
Official wording
Reason: Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Code information: Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.