FDARecalled Jan 1, 2025 · #D-0155-2025
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
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, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
- Type
- Drugs
- Manufacturer
- Amerisource Health Services LLC
- Model numbers
- DT3023029A
- UPCs
- —