FDAHealthApril 14, 2025
Breckenridge Pharmaceutical, Inc — Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceut
⚠️ CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 14, 2025
US Nationwide.
What's affected?
- Product
- 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
- Brand
- DULOXETINE
- Lot code
- 240987C
Additional details
Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 16,473 bottles.
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