Drug product
CYANOCOBALAMIN, Tablet, 500 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536355101.
D-932-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 700 Tablets
- Official record key
drug-enforcement:D-932-2014
Official wording
Reason: Labeling: Label Mixup:CYANOCOBALAMIN, Tablet, 500 mcg was mislabled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002859, EXP: 6/7/2014. and may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX W/C, Tablet, 0, NDC 00536730001, Pedigree: AD52993_7, EXP: 5/20/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD30180_22, EXP:
Code information: CYANOCOBALAMIN, Tablet, 500 mcg has the following codes: Pedigree: AD52993_19, EXP: 5/20/2014; Pedigree: AD30180_25, EXP: 5/9/2014; Pedigree: AD37056_10, EXP: 5/10/2014; Pedigree: AD60578_16, EXP: 5/29/2014; Pedigree: W002860, EXP: 6/7/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled