D-0212-2025 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 5, 2025
- Initiation Date
- January 13, 2025
- Termination Date
- March 5, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 6408 boxes and b)1488 boxes
Product Description
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA.
Reason for Recall
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025