Drug product
Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-704-86
D-0233-2022
Product summary
- Event
- Event 88997
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,766 bottles
- Official record key
drug-enforcement:D-0233-2022
Official wording
Reason: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Code information: Lot #: 07040001A, exp. date 02/2022
Distribution pattern: Product was distributed nationwide within the United States
Derived failure modes
-
Potency or specification failure
Subpotent