fda_recall · drug_recall · high
Direct Rx — Class II recall: DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60…
- Event date
- 2026-07-01 00:00:00Z
- Observed
- 2026-07-09 22:51:31Z
- Source ID
- D-0617-2026
- Payload hash
- cc25fcadfba94488e25fea8f…
Summary
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.