Drug product
SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
D-0834-2016
Product summary
- Event
- Event 73874
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,676 boxes
- Official record key
drug-enforcement:D-0834-2016
Official wording
Reason: Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Code information: Lot 0110701
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up