FDAHealthOctober 10, 2024
Breckenridge Pharmaceutical, Inc — Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
⚠️ 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
- October 10, 2024
Product was distributed nationwide within the United States
What's affected?
- Product
- Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
- Brand
- DULOXETINE
- Lot code
- 220128
Additional details
Lot #: 220128, Exp. Date 12/2024
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7,107 bottles.
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