DULOXETINE (DULOXETINE HYDROCHLORIDE)
Wed Mar 19 2025
1 of 15
Summary
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05 | Breckenridge Pharmaceutical, Inc. | Nationwide | 11,125 bottles. |
| Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 | Breckenridge Pharmaceutical, Inc. | Nationwide | 14,749 bottles. |
| Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10 | Breckenridge Pharmaceutical, Inc. | Nationwide | 11,100 bottles. |