D-0483-2024 Class II Ongoing
FDA drug recall D-0483-2024 was initiated by Breckenridge Pharmaceutical, Inc on Apr 29, 2024 and is designated Class II. Reason for recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit The recall status is ongoing. Affected quantity: 7,188/ 500 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2024
- Initiation Date
- Apr 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,188/ 500 count bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution Pattern
US Nationwide.
Code Information
220456: Exp. Feb 2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0483-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026