D-0482-2024 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 & 1000 count bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Distribution Pattern
US Nationwide.
Code Information
220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025