FDAFDA · Food and drugs·Recall number D-0090-2024
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
Published November 15, 2023 · Recall initiated: October 27, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EXTENDED PHENYTOIN SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- Nationwide in the USA and Puerto Rico
- UPC
- 0365162212037
- Lot
- Lot # HM03221A, Exp. date 12/31/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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