D-0511-2025 Class II Ongoing
FDA drug recall D-0511-2025 was initiated by Breckenridge Pharmaceutical, Inc. on June 30, 2025 and is designated Class II. Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit The recall status is ongoing. Affected quantity: 12,242 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 16, 2025
- Initiation Date
- June 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,242 30-count bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution Pattern
U.S. Nationwide
Code Information
Lot # 230199, Exp. Date 01/31/2026