Drug product
ASPIRIN, CHEW Tablet, 81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536329736.
D-927-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4246 CHEW Tablets
- Official record key
drug-enforcement:D-927-2014
Official wording
Reason: Labeling: Label Mixup: ASPIRIN, CHEW Tablet, 81 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD30028_4, EXP: 5/8/2014; MODAFINIL, Tablet, 200 mg, NDC 00603466216, Pedigree: W002760, EXP: 6/6/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W003015, EXP: 6/12/2014; VITAMIN B COMPLEX
Code information: ASPIRIN, CHEW Tablet, 81 mg has the following codes: Pedigree: AD33897_1, EXP: 5/9/2014; Pedigree: W002773, EXP: 6/6/2014; Pedigree: W003093, EXP: 6/13/2014; Pedigree: W003459, EXP: 6/20/2014; Pedigree: AD49582_1, EXP: 5/16/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled