FDA recall D-661-2014

Aidapak Services, LLC · Class II · drug

Product

ATORVASTATIN CALCIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505257909

Reason for recall

Labeling:Label Mixup; ATORVASTATIN CALCIUM Tablet, 20 mg may be potentially mislabeled as guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003850, EXP: 6/27/2014.

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-661-2014