Duloxetine Delayed-Release Capsules recalled over manufacturing violations
- Recall date
- December 6, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutic…
- Recall number
- D-0161-2025
- FDA classification
- Class II
- Brand / firm
- Breckenridge Pharmaceutical, Inc
- Sold / distributed
- Nationwide in the US
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, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
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