FDA Drug Class II — Moderate

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

Hazard

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

Products

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
Brand
Sandoz Incorporated
UPC
Lot GG1539

Units Affected

96 bottles