Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 C…
| Source | FDA · Drugs |
|---|---|
| Date | 2026-06-17 |
| Product | Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. |
| Reason / hazard | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit |
| Classification | Class II |
| Official notice | — |
| Record ID | fda-drug:D-0583-2026 |