D-0387-2025 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
- 16,473 bottles
Product Description
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
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Distribution Pattern
US Nationwide.
Code Information
Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027