FDAHealthJanuary 29, 2025
Glenmark Pharmaceuticals Inc., USA — Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
⚠️ CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 29, 2025
Nationwide within the U.S
What's affected?
- Product
- Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.
- Brand
- ATOMOXETINE
- UPC
- 0368462265307
- Lot code
- 19234109
Additional details
Lot Numbers: 19234109, Exp.: 9/2025; 19234897, Exp.: 11/2025; 19240501, Exp.: 1/2026; 19241489, Exp.: 3/2026; 19241806, Exp.: 4/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 190,320 bottles.
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