FDA recall D-0261-2019

Sandoz Inc · Class II · drug

Product

Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00

Reason for recall

Cross Contamination with Other Products

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2018-11-02
Report date
2018-11-21
Termination date
2020-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0261-2019