FDARecalled Feb 26, 2025 · #D-0243-2025
Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
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, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.
- Type
- Drugs
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Model numbers
- Numbers
- UPCs
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