Recalls / Class II

Class IID-621-2014

Product

tiZANidine HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915

Affected lot / code info

tiZANidine HCl, Tablet, 2 mg has the following codes Pedigree: AD21790_40, EXP: 5/1/2014; Pedigree: AD46265_16, EXP: 5/15/2014; Pedigree: W002663, EXP: 6/5/2014; Pedigree: AD73525_31, EXP: 5/30/2014.

Why it was recalled

Labeling:Label Mixup; tiZANidine HCl Tablet, 2 mg may be potentially mislabeled as RIBAVIRIN, Capsule, 200 mg, NDC 68382026007, Pedigree: AD21790_37, EXP: 4/30/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD46257_59, EXP: 5/15/2014; NIACIN, Tablet, 100 mg, NDC 00904227160, Pedigree: W002661, EXP: 6/5/2014; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 00008060601, Pedigree

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

600 Tablets

Distribution pattern

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

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-16

Posted by FDA

2014-01-22

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-621-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.