Drug product
ASPIRIN DR EC, Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182106105.
D-875-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1499 Tablets
- Official record key
drug-enforcement:D-875-2014
Official wording
Reason: Labeling: Label Mixup: ASPIRIN DR EC, Tablet, 81 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 120 mg, NDC 00093106001, Pedigree: AD49448_20, EXP: 5/17/2014; FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: W003097, EXP: 6/13/2014.
Code information: ASPIRIN DR EC, Tablet, 81 mg has the following codes: Pedigree: AD52433_1, EXP: 5/17/2014; Pedigree: W003094, EXP: 6/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled