Recalls / Class II

Class IID-933-2014

Product

CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536355601.

Affected lot / code info

CYANOCOBALAMIN, Tablet, 1000 mcg may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD30180_19, EXP: 5/9/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD37056_4, EXP: 5/10/2014. VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 0, NDC 40985022251, Pedigree: AD73627_26, EXP: 5/30/2014; PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W003856, EXP: 6/26/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003052, EXP: 6/12/2014; VENLAFAXINE HCL, Tablet, 50 mg, NDC 23155024801, Pedigree: AD65475_22, EXP: 5/28/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD32757_50, EXP: 5/14/2014.

Why it was recalled

Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 1000 mcg may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD30180_19, EXP: 5/9/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD37056_4, EXP: 5/10/2014. VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 0, NDC 40985022251, Pedigree: AD7362

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

923 Tablets

Distribution pattern

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

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-20

Posted by FDA

2014-01-29

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-933-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.