Drug product
CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536355601.
D-933-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 923 Tablets
- Official record key
drug-enforcement:D-933-2014
Official wording
Reason: 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
Code information: 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.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled