FDA-Drug2017-01-04Class II

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

Sandoz Incorporated
Hazard

Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)

Sold states
MS and OH.
Affected count
96 bottles
Manufactured in
2555 W Midway Blvd, N/A, Broomfield, CO, United States
Products
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0236-2017

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