D-0484-2024 Class II Ongoing
FDA drug recall D-0484-2024 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: 281,554/90 count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2024
- Initiation Date
- Apr 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 281,554/90 count bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution Pattern
US Nationwide.
Code Information
230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: 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-0484-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026