D-0271-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 19, 2025
- Initiation Date
- February 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,125 bottles.
Product Description
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Distribution Pattern
Nationwide
Code Information
Lot#: 240098C, Expiration: 01/2027.