FDAHealthFebruary 28, 2025
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Br
⚠️ CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 28, 2025
Nationwide
What's affected?
- Product
- Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10
- Brand
- DULOXETINE
- Lot code
- 240301C
Additional details
Lot#: 240301C, Expiration: 01/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11,100 bottles..
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