Dr. Reddy's Laboratories, Inc. recalls Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 In…
- Recall date
- December 28, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0451-2017
- FDA classification
- Class II
- Brand / firm
- Dr. Reddy's Laboratories, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Dissolution Specifications; 18 month stability 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
Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12
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