FDA recall D-972-2014

Aidapak Services, LLC · Class II · drug

Product

CYCLOBENZAPRINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591325601.

Reason for recall

Labeling: Label Mixup: CYCLOBENZAPRINE HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD46257_62, EXP: 5/15/2014; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304062101, Pedigree: AD73525_1, EXP: 5/30/2014.

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-972-2014