FDA Recall D-0258-2024
IntegraDose Compounding Services LLC · Minneapolis, MN
Class II Ongoing 853 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
Reason for recall
Subpotent Drug
Recall record
- Recall number
D-0258-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- MN only
- Recall initiated
- 2024-01-12
- Classified by FDA Center
- 2024-01-22
- FDA published
- 2024-01-31
- 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.