Recalls / Class II

Class IID-696-2014

Product

COLCHICINE Tablet, 0.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764011907

Affected lot / code info

COLCHICINE Tablet, 0.6 mg has the following codes Pedigree: AD46419_1, EXP: 5/16/2014; Pedigree: AD52778_22, EXP: 5/20/2014; Pedigree: AD65457_1, EXP: 5/23/2014; Pedigree: W003612, EXP: 6/25/2014; Pedigree: W002961, EXP: 6/11/2014.

Why it was recalled

Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

150 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-696-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.