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, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceuti…
- Recall number
- D-0162-2025
- 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, 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.
Get recall alerts
Free email alert whenever Breckenridge Pharmaceutical, Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Breckenridge Pharmaceutical, Inc