FDA-Drug2017-04-05Class II
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Zydus Pharmaceuticals USA Inc
Hazard
Failed Dissolution Specifications; 9 month long term stability
Sold states
Nationwide
Affected count
32628 bottles
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0617-2017Don't want to check this manually?
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