FDAHealthAugust 8, 2025
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Sp
⚠️ CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Is this relevant to me?
- Geography
- AZ, IN, NJ
- Source agency
- FDA
- Category
- Health
- Published
- August 8, 2025
AZ, IN, NJ
What's affected?
- 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
- Brand
- DULOXETINE
- Lot code
- 240927C
Additional details
Lot 240927C, Exp 04/30/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,591 bottles.
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