Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories…
- Recall date
- May 22, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1136-2015
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
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, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
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