FDARecalled Jun 10, 2026 · #D-0555-2026
Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
Hazard
Class II — temporary health risk
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CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. Classification: Class II Distribution: US Nationwide.
Product details
- Product
- Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc.
- Type
- Drugs
- Manufacturer
- Asclemed USA Inc.
- Model numbers
- 050725G-30
- UPCs
- —