Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, 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.
This recall is currently active, issued May 15, 2024. It was issued by Breckenridge Pharmaceutical, Inc.
- Company
- Breckenridge Pharmaceutical, Inc
- Recall Initiated
- April 29, 2024
- Posted
- May 15, 2024
- Recall Number
- D-0484-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 281,554/90 count 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
US Nationwide.
Lot / Code Info
230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: Exp. Feb 2025
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