FDA-Drug2023-06-21Class II
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.
Amneal Pharmaceuticals of New York, LLC
Hazard
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Sold states
LA, PA and OH.
Affected count
9,056 bottles
Manufactured in
50 Horseblock Rd, N/A, Brookhaven, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0876-2023Don't want to check this manually?
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