FDA recall D-1036-2016

Sandoz Inc · Class III · drug

Product

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01

Reason for recall

Labeling: Incorrect or Missing Package Insert

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-05-25
Report date
2016-06-22
Termination date
2017-04-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1036-2016