FDA recall D-689-2014

Aidapak Services, LLC · Class II · drug

Product

PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304

Reason for recall

Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status
Terminated
Initiation date
2013-07-02
Report date
2014-01-22
Termination date
2014-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-689-2014