Class II
Ongoing
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
This recall is currently active, issued January 1, 2025. It was issued by Amerisource Health Services Llc.
- Company
- Amerisource Health Services Llc
- Recall Initiated
- December 6, 2024
- Posted
- January 1, 2025
- Recall Number
- D-0155-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 21,262 bottles
- Firm Location
- Columbus, OH, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Distribution
Nationwide in the USA
Lot / Code Info
Lot DT3023029A Exp 02/28/2025
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