FDA-Drug2024-04-03Class II
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
Amneal Pharmaceuticals of New York, LLC
Hazard
Failed dissolution specifications
Sold states
Product was distributed nationwide.
Affected count
21,452/100 count bottles
Manufactured in
50 Horseblock Rd, N/A, Brookhaven, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0426-2024Don't want to check this manually?
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