Class II
Terminated
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.
- Recall Initiated
- May 30, 2023
- Posted
- June 21, 2023
- Recall Number
- D-0876-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,056 bottles
- Firm Location
- Brookhaven, NY, United States
Reason for Recall
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Distribution
LA, PA and OH.
Lot / Code Info
Lot # HL00721A, Exp. 12/2023
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