Drug product
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310
D-1391-2019
Product summary
- Event
- Event 82983
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9360 tubes
- Official record key
drug-enforcement:D-1391-2019
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot 11852, exp date 08/2020
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications