FDAFDA · Food and drugs·Recall number D-0876-2023
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.
Published June 21, 2023 · Recall initiated: May 30, 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: Out-of-specification results for dissolution (above specification)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EXTENDED PHENYTOIN SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- LA, PA and OH.
- UPC
- 0365162212037
- Lot
- Lot # HL00721A, Exp. 12/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.