PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 4, 2017 Initiated: December 22, 2016 #D-0236-2017

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Sandoz Incorporated
Units Affected
96 bottles
Distribution
MS and OH.
Location
Broomfield, CO

Frequently Asked Questions

What product was recalled?
Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10. Recalled by Sandoz Incorporated. Units affected: 96 bottles.
Why was this product recalled?
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Which agency issued this recall?
This recall was issued by the FDA Drug on January 4, 2017. Severity: Moderate. Recall number: D-0236-2017.