Recalls / Class II
Class IID-0100-2025
Product
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
- Affected lot / code info
- a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Recalling firm
- Firm
- Amerisource Health Services LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 23,490 bottles
- Distribution pattern
- PA, OH, PR
Timeline
- Recall initiated
- 2024-11-14
- FDA classified
- 2024-12-03
- Posted by FDA
- 2024-12-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0100-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.