Recalls / Class II
Class IID-0432-2024
Product
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1
- Affected lot / code info
- Lot#: 20231020FEN-1, Exp: 04/17/2024
Why it was recalled
Lack of Assurance of Sterility: leaking bags
Recalling firm
- Firm
- IntegraDose Compounding Services LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 719 Kasota Ave Se, Minneapolis, Minnesota 55414-2842
Distribution
- Quantity
- 187 cassettes
- Distribution pattern
- Nationwide within the U.S
Timeline
- Recall initiated
- 2024-03-22
- FDA classified
- 2024-04-03
- Posted by FDA
- 2024-04-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0432-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.