Amneal Pharmaceuticals of New York, LLC: Drug Recall
Recall #D-0876-2023 · 05/30/2023
Class II: Risk
Recall Details
- Recall Number
- D-0876-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Status
- Terminated
- Date Initiated
- 05/30/2023
- Location
- Brookhaven, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,056 bottles
Reason for Recall
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Product Description
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Distribution Pattern
LA, PA and OH.
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.