Class II
Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
This recall is currently active, issued December 11, 2024. It was issued by Amerisource Health Services Llc.
- Company
- Amerisource Health Services Llc
- Recall Initiated
- November 14, 2024
- Posted
- December 11, 2024
- Recall Number
- D-0100-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23,490 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
PA, OH, PR
Lot / Code Info
a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
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