Drug 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
D-0387-2025
Product summary
- Event
- Event 96707
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16,473 bottles
- Official record key
drug-enforcement:D-0387-2025
Official wording
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Code information: Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Nitrosamine Drug Substance Related Impurity
-
Manufacturing or process control
CGMP Deviations