Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Medium |
| Status | ongoing |
| Recall date | April 21, 2026 |
| Reported | May 13, 2026 |
| Recalling firm | Breckenridge Pharmaceutical, Inc. |
| Country / region | United States NJ |
Hazard
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Affected products
- Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Br
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