Drug product
ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00597000160.
D-980-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Capsules
- Official record key
drug-enforcement:D-980-2014
Official wording
Reason: Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been mislabeled as the following drug: THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD70639_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: W003439, EXP: 6/20/2014; ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: W003641, EXP: 6/25/2014.
Code information: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg has the following codes: Pedigree: AD70639_4, EXP: 7/28/2013; Pedigree: W003468, EXP: 8/19/2013; Pedigree: W003644, EXP: 8/24/2013.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled