FDAFDA · Food and drugs·Recall number D-0426-2024
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
Published April 3, 2024 · Recall initiated: December 26, 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
- DIVALPROEX SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- Product was distributed nationwide.
- UPC
- 0365162755107
- Lot
- Lot # AR210704, exp. date 04/2024 AR210706, exp. date 04/2024 AR210707, exp. date 04/2024 AR210708, exp. date 04/2024 AR210709, exp. date 04/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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