D-0157-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 1, 2025
- Initiation Date
- December 6, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,734 30-count bottles
Product Description
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Distribution Pattern
Nationwide in the USA
Code Information
Lot DT6023061B Exp 01/31/2025