FDARecalled Jan 1, 2025 · #D-0158-2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
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: Nationwide in the USA
Product details
- Product
- Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
- Type
- Drugs
- Manufacturer
- Amerisource Health Services LLC
- Model numbers
- DT6022166A, DT6023071A
- UPCs
- —