Sandoz Incorporated recalls Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, N…
- Recall date
- December 22, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0236-2017
- FDA classification
- Class II
- Brand / firm
- Sandoz Incorporated
- Sold / distributed
- MS and OH.
Why it was recalled
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
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