FDA-Drug2015-06-24Class II

Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01

Dr. Reddy's Laboratories, Inc.
Hazard

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

Sold states
Nationwide
Affected count
5,160 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1136-2015

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