FDA-Drug2015-06-24Class II
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Dr. Reddy's Laboratories, Inc.
Hazard
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
Sold states
Nationwide
Affected count
100 count 7479; 500 count - 2544
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1135-2015Don't want to check this manually?
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