D-0244-2025 Class II Ongoing
FDA drug recall D-0244-2025 was initiated by Glenmark Pharmaceuticals Inc., USA on January 29, 2025 and is designated Class II. Reason for recall: CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit. The recall status is ongoing. Affected quantity: 58,368 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 26, 2025
- Initiation Date
- January 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58,368 bottles
Product Description
Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.
Reason for Recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Distribution Pattern
Nationwide within the U.S
Code Information
Lot Numbers: 19233270, 19233278, 19233285, Exp.: 7/2025; 19233806, Exp.: 8/2025; 19240954, Exp.: 2/2026; 19241854, Exp.: 4/2026.