FDA-Drug2017-08-09Class II
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Zydus Pharmaceuticals USA Inc
Hazard
Failed Dissolution Specifications
Sold states
Nationwide
Affected count
108,726 HDPE bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1043-2017Don't want to check this manually?
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