FDA-Drug2025-02-26Class II
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Sold states
Nationwide within the U.S
Affected count
39,168 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0237-2025Don't want to check this manually?
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