D-0388-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- April 30, 2025
- Initiation Date
- April 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 343,344 bottles
Product Description
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.
Distribution Pattern
US Nationwide.
Code Information
Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026