D-0231-2025 Class II Ongoing
FDA drug recall D-0231-2025 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: 70,032 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
- 70,032 bottles
Product Description
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
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: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.