Drug product
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01
D-0538-2026
Product summary
- Event
- Event 98885
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 149 capsules
- Official record key
drug-enforcement:D-0538-2026
Official wording
Reason: Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Code information: Lot #: 25530722
Distribution pattern: TX only
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up