FDA recall D-1140-2015

American Health Packaging · Class II · drug

Product

Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11

Reason for recall

Failed dissolution specifications

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-03-02
Report date
2015-06-24
Termination date
2015-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1140-2015