Drug product
PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052060.
D-1017-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 403 Tablets
- Official record key
drug-enforcement:D-1017-2014
Official wording
Reason: Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 mg, NDC 04746900466, Pedigree: AD21846_17, EXP: 5/1/2014; METHOCARBAMOL, Tablet, 500 mg, NDC 00143129001, Pedigree: AD46312_28, EXP: 5/16/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00074929690, Pedigree: AD22865_16, EXP: 5/2/2014; RILUZOLE, Tablet,
Code information: PYRIDOXINE HCL, Tablet, 50 mg has the following codes: Pedigree: AD22865_19, EXP: 5/2/2014; Pedigree: AD46312_34, EXP: 5/16/2014; Pedigree: AD22865_22, EXP: 5/2/2014; Pedigree: W003257, EXP: 6/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled