Duloxetine Delayed-Release Capsules recalled over manufacturing violations
- Recall date
- October 10, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. D…
- Recall number
- D-0009-2025
- FDA classification
- Class II
- Brand / firm
- Breckenridge Pharmaceutical, Inc
- Sold / distributed
- Product was distributed nationwide within the United States
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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