Status
Ongoing
Drug Enforcement D-0325-2024
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Classification
Class II
Report Date
February 21, 2024
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 1,299 syringes
- Reason for recall
- Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- MN
Location & Firm
- Recalling firm
- IntegraDose Compounding Services LLC
- Address
-
719 Kasota Ave Se, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0325-2024
- Event ID
- 93940
- Recall initiation date
- January 22, 2024
- Center classification date
- February 15, 2024
- 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
- More code info
- —