FDA recall D-0236-2017

Sandoz Incorporated · Class II · drug

Product

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%)

Distribution

MS and OH.

Key facts

Status
Terminated
Initiation date
2016-12-22
Report date
2017-01-04
Termination date
2017-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Broomfield, CO, United States

Primary source

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