D-0156-2025 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
- 13,678 bottles
Product Description
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
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 DT3023030A Exp 2/28/2025