FDA-Drug2019-02-27Class II

Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01

Dr. Reddy's Laboratories, Inc.
Hazard

Failed Dissolution Specifications: Out of specification results observed for high dissolution.

Sold states
U.S.A. Nationwide
Affected count
10,656 bottles
Manufactured in
107 College Rd E, Princeton, NJ, United States
Products
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0507-2019

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