FDAHealthDecember 6, 2024
Breckenridge Pharmaceutical, Inc — Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spa
⚠️ 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
- December 6, 2024
Nationwide in the US
What's affected?
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
- Brand
- DULOXETINE
- Lot code
- 230077C
Additional details
Lot # 230077C, exp. date 11/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 76,968 bottles.
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