Drug product
THIAMINE HCL, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904054460.
D-1022-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Tablets
- Official record key
drug-enforcement:D-1022-2014
Official wording
Reason: Labeling: Label Mixup: THIAMINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 5 mg, NDC 00093715298, Pedigree: AD65323_13, EXP: 5/29/2014; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, NDC 00904323392, Pedigree: AD54576_1, EXP: 5/20/2014; BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD54478_1, EXP: 5/20/2014; P
Code information: THIAMINE HCL, Tablet, 100 mg has the following codes: Pedigree: AD70639_1, EXP: 5/29/2014; Pedigree: AD54559_1, EXP: 5/20/2014; Pedigree: AD52993_16, EXP: 5/20/2014; Pedigree: W003408, EXP: 6/19/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled