NDC 50090-7342
atomoxetine 25 mg capsule
On the label: A-S Medication Solutions. It's repackaged: A-S Medication Solutions rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-267.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Repackaging site
- A-S Medication Solutions LLC, Libertyville, IL, United States · relabels it
Recalls
- Jan 29, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Lots: Lot Numbers: 19233792, Exp.: 8/2025; 19233795, Exp.: 8/2025; 19234258, Exp.: 9/2025; 19240912, Exp.: 2/2026; 19241476, 19241477, Exp.: 3/2026; 19242599, Exp.: 6/2026; 19243163, 19243162, Exp.:7/2026;19243884, 19243887, Exp.:9/2026.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atomoxetine: every company that makes it
- Form
- capsule, oral
- Strength
- 25 mg
- Approval
- ANDA ANDA079019
- On the market since
- May 30, 2017
- Package NDCs
50090-7342-0- Official label
- DailyMed (National Library of Medicine), updated Oct 21, 2024
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