D-0562-2024 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- June 26, 2024
- Initiation Date
- May 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 165,678, 90-count bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025