Atomoxetine Capsules recalled over manufacturing violations
- Recall date
- January 29, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141,…
- Recall number
- D-0243-2025
- FDA classification
- Class II
- Brand / firm
- Glenmark Pharmaceuticals Inc., USA
- Sold / distributed
- Nationwide within the U.S
Why it was recalled
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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