Class II
Completed
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.
- Company
- Breckenridge Pharmaceutical, Inc
- Recall Initiated
- October 10, 2024
- Posted
- October 23, 2024
- Recall Number
- D-0009-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 7,107 bottles
- Firm Location
- Berlin, CT, United States
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution
Product was distributed nationwide within the United States
Lot / Code Info
Lot #: 220128, Exp. Date 12/2024
More recalls by Breckenridge Pharmaceutical, Inc
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Jan 1, 2025 · Class II
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