D-0484-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2024
- Initiation Date
- April 29, 2024
- Termination Date
- N/A
- 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