fda_recall · drug_recall · high
Asclemed USA Inc. — Class II recall: Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pha…
- Event date
- 2026-06-10 00:00:00Z
- Observed
- 2026-07-09 22:51:38Z
- Source ID
- D-0555-2026
- Payload hash
- 7e3523fbf11a4c44229d04bf…
Summary
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.