Class II
Ongoing
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
This recall is currently active, issued February 26, 2025. It was issued by Glenmark Pharmaceuticals Inc., Usa.
- Recall Initiated
- January 29, 2025
- Posted
- February 26, 2025
- Recall Number
- D-0238-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 120,000 bottles
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Distribution
Nationwide within the U.S
Lot / Code Info
Lot Numbers: 19232356, Exp.: 5/2025; 19233198, Exp.: 7/2025; 19234213, 19234232, Exp.: 9/2025; 19241445, Exp.: 3/2026; 19243033, 19243121, Exp.: 7/2026.
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