FDA recall D-0876-2023

Amneal Pharmaceuticals of New York, LLC · Class II · drug

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)

Distribution

LA, PA and OH.

Key facts

Status: Terminated
Initiation date: 2023-05-30
Report date: 2023-06-21
Termination date: 2025-06-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0876-2023