D-0876-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 21, 2023
- Initiation Date
- May 30, 2023
- Termination Date
- June 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,056 bottles
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.
Reason for Recall
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Distribution Pattern
LA, PA and OH.
Code Information
Lot # HL00721A, Exp. 12/2023