Class II
Ongoing
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
This recall is currently active, issued April 30, 2025. It was issued by Breckenridge Pharmaceutical, Inc.
- Company
- Breckenridge Pharmaceutical, Inc
- Recall Initiated
- April 14, 2025
- Posted
- April 30, 2025
- Recall Number
- D-0387-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,473 bottles
- Firm Location
- Berlin, CT, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Distribution
US Nationwide.
Lot / Code Info
Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027
More recalls by Breckenridge Pharmaceutical, Inc
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Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceut...
Oct 23, 2024 · Class II
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