Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
This recall is currently active, issued March 19, 2025. It was issued by Breckenridge Pharmaceutical, Inc..
- Recall Initiated
- February 28, 2025
- Posted
- March 19, 2025
- Recall Number
- D-0271-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,125 bottles.
- Firm Location
- Berkeley Heights, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Distribution
Nationwide
Lot / Code Info
Lot#: 240098C, Expiration: 01/2027.
More recalls by Breckenridge Pharmaceutical, Inc.
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