FDARecalled Sep 17, 2025 · #D-0621-2025
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 ...
Hazard
Class II — temporary health risk
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CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. Classification: Class II Distribution: AZ, IN, NJ
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Breckenridge Pharmaceutical, Inc.
- Model numbers
- 240927C
- UPCs
- —