Class II
Completed
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
- Company
- Breckenridge Pharmaceutical, Inc
- Recall Initiated
- May 17, 2024
- Posted
- June 26, 2024
- Recall Number
- D-0562-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 165,678, 90-count bottles
- Firm Location
- Berlin, CT, United States
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
More recalls by Breckenridge Pharmaceutical, Inc
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Apr 30, 2025 · Class II
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Jan 1, 2025 · Class II
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