Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
This recall is currently active, issued January 1, 2025. It was issued by Breckenridge Pharmaceutical, Inc.
- Company
- Breckenridge Pharmaceutical, Inc
- Recall Initiated
- December 6, 2024
- Posted
- January 1, 2025
- Recall Number
- D-0162-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 76,968 bottles
- Firm Location
- Berlin, CT, 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 in the US
Lot / Code Info
Lot # 230077C, exp. date 11/2025
More recalls by Breckenridge Pharmaceutical, Inc
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Apr 30, 2025 · Class II
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Oct 23, 2024 · Class II
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Jun 26, 2024 · Class II
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