Recalls / Class II
Class IID-0325-2024
Product
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.
- Affected lot / code info
- Lot #s: 20230929VAS-2, Exp. 02/29/2024; 20231004VAS-2, Exp. 04/01/2024; Lot 20231010VAS-2,Exp. 04/07/2024; Lot 20231013VAS-2, Exp. 04/10/2024
Why it was recalled
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Recalling firm
- Firm
- IntegraDose Compounding Services LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 719 Kasota Ave Se, N/A, Minneapolis, Minnesota 55414-2842
Distribution
- Quantity
- 1,299 syringes
- Distribution pattern
- MN
Timeline
- Recall initiated
- 2024-01-22
- FDA classified
- 2024-02-15
- Posted by FDA
- 2024-02-21
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0325-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.