D-0162-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 1, 2025
- Initiation Date
- December 6, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76,968 bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Reason for Recall
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Distribution Pattern
Nationwide in the US
Code Information
Lot # 230077C, exp. date 11/2025