Drug product
Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
D-0297-2022
Product summary
- Event
- Event 88550
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,792 bottles
- Official record key
drug-enforcement:D-0297-2022
Official wording
Reason: Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing
Code information: Lot # 16569, Exp 9/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications