FDARecalled Feb 26, 2025 · #D-0237-2025
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
Hazard
Class II — temporary health risk
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CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. Classification: Class II Distribution: Nationwide within the U.S
Product details
- Product
- Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
- Type
- Drugs
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Model numbers
- Numbers
- UPCs
- —