fda_recall · drug_recall · high
Breckenridge Pharmaceutical, Inc. — Class II recall: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, M…
- Event date
- 2026-06-17 00:00:00Z
- Observed
- 2026-07-09 22:51:36Z
- Source ID
- D-0582-2026
- Payload hash
- de88d7c62b26b64fd31b2907…
Summary
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Status: Ongoing.
Informational only. Not legal, financial, or medical advice.