Class II · Moderate risk Ongoing
Atomoxetine Capsules HCL
Reason Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Atomoxetine HCL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup: ATOMOXETINE HCL, Capsule, 80 mg may be potentially mis-labeled as one of the following drugs: ATOMOXETINE HCL, Capsule, 18 mg, NDC 00002323830, Pedigree: AD30140_16, EXP: 5/7/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, 0 mg, NDC 00904531360, Pedigree: W003706, EXP: 6/25/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD60272_40, EXP: 5/22/2014; PRO
What was recalled
ATOMOXETINE HCL, Capsule, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002325030.
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-768-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Atomoxetine recalls
See all
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II · Moderate risk Ongoing
Atomoxetine Capsules
Reason CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
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