D-0621-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- September 17, 2025
- Initiation Date
- August 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,591 bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
Reason for Recall
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Distribution Pattern
AZ, IN, NJ
Code Information
Lot 240927C, Exp 04/30/2027