FDA-Drug2023-11-15Class II
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Amneal Pharmaceuticals of New York, LLC
Hazard
Failed Dissolution Specifications
Sold states
Nationwide in the USA and Puerto Rico
Affected count
9,263 100-count bottles
Manufactured in
50 Horseblock Rd, Brookhaven, NY, United States
Products
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0090-2024Don't want to check this manually?
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