D-0580-2025 Class II Ongoing
FDA drug recall D-0580-2025 was initiated by Breckenridge Pharmaceutical, Inc. on July 25, 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: 1,856 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 20, 2025
- Initiation Date
- July 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,856 bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Distribution Pattern
NJ, AZ, IN
Code Information
Lot 240539C, Exp 1/31/2027