D-0009-2025 Class II
FDA drug recall D-0009-2025 was initiated by Breckenridge Pharmaceutical, Inc on October 10, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Affected quantity: 7,107 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 23, 2024
- Initiation Date
- October 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,107 bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution Pattern
Product was distributed nationwide within the United States
Code Information
Lot #: 220128, Exp. Date 12/2024