Amneal Pharmaceuticals of New York, LLC: Drug Recall
Recall #D-0234-2022 · 11/04/2021
Class II: Risk
Recall Details
- Recall Number
- D-0234-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Status
- Terminated
- Date Initiated
- 11/04/2021
- Location
- Brookhaven, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,88 bottles
Reason for Recall
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
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
Distribution Pattern
Product was distributed nationwide within the United States
Other Recalls by Amneal Pharmaceuticals of New York, LLC
- Class II: Risk 03/25/2024
- Class I: Dangerous 03/21/2024
- Class II: Risk 02/13/2024
- Class II: Risk 01/15/2024
- Class II: Risk 12/26/2023
View all recalls by Amneal Pharmaceuticals of New York, LLC →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.