D-0234-2022 Class II Terminated
FDA drug recall D-0234-2022 was initiated by Amneal Pharmaceuticals of New York, LLC on November 4, 2021 and is designated Class II. Reason for recall: Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. The recall status is terminated (terminated June 9, 2022). Affected quantity: 15,88 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- November 24, 2021
- Initiation Date
- November 4, 2021
- Termination Date
- June 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,88 bottles
Product Description
Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bottle, Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807, NDC 65162-703-86
Reason for Recall
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Distribution Pattern
Product was distributed nationwide within the United States
Code Information
Lot #: 07030002A, exp. date 02/2022