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.

FDA recall notice · announced June 21, 2023 · Amneal Pharmaceuticals Of New York

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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)

Notes

Distribution: LA, PA and OH.
Lot/code information: Lot # HL00721A, Exp. 12/2023
Quantity: 9,056 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0876-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.