FDAHealthApril 14, 2025
Breckenridge Pharmaceutical, Inc — Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Ph
⚠️ 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, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
- Brand
- DULOXETINE
- Lot code
- 230201C
Additional details
Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 343,344 bottles.
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