FDA recall D-680-2014

Aidapak Services, LLC · Class II · drug

Product

ESZOPICLONE, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402019310

Reason for recall

Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.

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-680-2014