Class II
Terminated
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.
This recall has been terminated (originally issued February 5, 2025).
- Recall Initiated
- January 13, 2025
- Posted
- February 5, 2025
- Recall Number
- D-0212-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 6408 boxes and b)1488 boxes
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: a) N01530, Exp. Date 01/2025; b) N01540, Exp. Date. 01/2025
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