Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
This recall is currently active, issued April 9, 2025. It was issued by Breckenridge Pharmaceutical, Inc..
- Recall Initiated
- March 26, 2025
- Posted
- April 9, 2025
- Recall Number
- D-0308-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,863 bottles
- Firm Location
- Berkeley Heights, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Distribution
Nationwide in the US
Lot / Code Info
Lot 240909C, Exp Date 03/31/2027
More recalls by Breckenridge Pharmaceutical, Inc.
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