FDA Recall D-0432-2024
IntegraDose Compounding Services LLC · Minneapolis, MN
Class II Ongoing 783 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Lack of Assurance of Sterility: leaking bags
Recall record
- Recall number
D-0432-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the U.S
- Recall initiated
- 2024-03-22
- Classified by FDA Center
- 2024-04-03
- FDA published
- 2024-04-10
- Recalling firm
- IntegraDose Compounding Services LLC
- Firm location
- Minneapolis, MN
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.