Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Lim…
- Recall date
- January 31, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0507-2019
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- U.S.A. Nationwide
Why it was recalled
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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