FDARecalled Dec 11, 2024 · #D-0099-2025
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit Classification: Class II Distribution: PA, OH, PR
Product details
- Product
- Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
- Type
- Drugs
- Manufacturer
- Amerisource Health Services LLC
- Model numbers
- —
- UPCs
- —