D-0099-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2024
- Initiation Date
- November 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,916 bottles
Product Description
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
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Distribution Pattern
PA, OH, PR
Code Information
Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025