D-0308-2025 Class II Ongoing
FDA drug recall D-0308-2025 was initiated by Breckenridge Pharmaceutical, Inc. on March 26, 2025 and is designated Class II. Reason for recall: CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. The recall status is ongoing. Affected quantity: 14,863 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 9, 2025
- Initiation Date
- March 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,863 bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
Reason for Recall
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Distribution Pattern
Nationwide in the US
Code Information
Lot 240909C, Exp Date 03/31/2027