FDA recall D-819-2014

Aidapak Services, LLC · Class II · drug

Product

VALSARTAN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078042315.

Reason for recall

Labeling: Label Mixup: VALSARTAN, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD52372_4, EXP: 5/17/2014; ZINC SULFATE, Capsule, 50 mg, NDC 00904533260, Pedigree: AD30994_8, EXP: 5/9/2014.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
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-819-2014