FDA recall D-0943-2017

Sandoz Incorporated · Class III · drug

Product

Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540

Reason for recall

Cross Contamination With Other Product: Imipramine

Distribution

Product was distributed throughout the United States

Key facts

Status: Terminated
Initiation date: 2017-06-16
Report date: 2017-07-12
Termination date: 2019-01-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0943-2017