FDA-Drug2022-08-31Class II
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Amneal Pharmaceuticals of New York, LLC
Hazard
Failed dissolution specifications.
Sold states
USA nationwide
Affected count
4,309 bottles
Manufactured in
50 Horseblock Rd, Brookhaven, NY, United States
Products
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1362-2022Don't want to check this manually?
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