Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Reported: November 15, 2023 Initiated: October 27, 2023 #D-0090-2024
Product Description
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Units Affected
- 9,263 100-count bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 9,263 100-count bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 15, 2023. Severity: Moderate. Recall number: D-0090-2024.
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