Drug product
ASPIRIN EC DR Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348098015
D-585-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 544 Tablets
- Official record key
drug-enforcement:D-585-2014
Official wording
Reason: Labeling: Label Mixup; ASPIRIN EC DR Tablet, 81 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD28322_7, EXP: 5/6/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: W003671, EXP: 6/25/2014.
Code information: ASPIRIN EC DR, Tablet, 81 mg has the following codes Pedigree: AD28349_1, EXP: 2/28/2014; Pedigree: W003672, EXP: 2/28/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled