Amneal Pharmaceuticals of New York, LLC: Drug Recall

Recall #D-0090-2024 · 10/27/2023

Class II: Risk

Recall Details

Recall Number: D-0090-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Amneal Pharmaceuticals of New York, LLC
Status: Terminated
Date Initiated: 10/27/2023
Location: Brookhaven, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,263 100-count bottles

Reason for Recall

Failed Dissolution Specifications

Product Description

Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10

Distribution Pattern

Nationwide in the USA and Puerto Rico

Other Recalls by Amneal Pharmaceuticals of New York, LLC

Class II: Risk 03/25/2024

Failed Dissolution Specifications
Class I: Dangerous 03/21/2024

Superpotent Drug: Due to overfilling of drug powder
Class II: Risk 02/13/2024

Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II: Risk 01/15/2024

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Class II: Risk 12/26/2023

Failed dissolution specifications

View all recalls by Amneal Pharmaceuticals of New York, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.