DULOXETINE (DULOXETINE HYDROCHLORIDE)
Wed Jan 01 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, 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. | Breckenridge Pharmaceutical, Inc. | Nationwide in the US | 163,883 bottles |
| 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. | Breckenridge Pharmaceutical, Inc. | Nationwide in the US | 76,968 bottles |