Drug recall D-0388-2025
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
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lots and codes
Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026
Recall details
- Recalling firm
- Breckenridge Pharmaceutical, Inc, Berlin, CT
- Quantity
- 343,344 bottles
- Distribution
- US Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 14, 2025
Related products
- Duloxetine – drug information
- NDC 51991-747 Duloxetine Delayed-Release · Duloxetine Hydrochloride 30 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-750 Duloxetine Delayed-Release · Duloxetine Hydrochloride 40 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-748 Duloxetine Delayed-Release · Duloxetine Hydrochloride 60 mg/1 · Breckenridge Pharmaceutical, Inc.
- NDC 51991-746 Duloxetine Delayed-Release · Duloxetine Hydrochloride 20 mg/1 · Breckenridge Pharmaceutical, Inc.