Drug product
PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536440801.
D-941-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 695 Tablets
- Official record key
drug-enforcement:D-941-2014
Official wording
Reason: Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003787, EXP: 6/27/2014; LEVOTHYROXINE/ LIOTHYRONINE, Tablet, 19 mcg/4.5 mcg, NDC 42192032901, Pedigree: AD30197_19, EXP: 3/31/2014; CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, NDC 00
Code information: PYRIDOXINE HCL, Tablet, 50 mg has the following codes: Pedigree: W003824, EXP: 6/27/2014; Pedigree: AD30197_22, EXP: 5/9/2014; Pedigree: AD60428_10, EXP: 5/22/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled