Why it was recalled
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
MN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0325-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 22, 2024
- FDA report date
- Feb 21, 2024
- Quantity
- 1,299 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- IntegraDose Compounding Services LLC
Original FDA data
Every field from FDA enforcement report D-0325-2024, exactly as published.
Show all FDA fields
- City
- Minneapolis
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 93940
- Address
- 719 Kasota Ave Se
- Code information
- 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
- Postal code
- 55414-2842
- Report date
- Feb 21, 2024
- Product type
- Drugs
- Recall number
- D-0325-2024
- Classification
- Class II
- Recalling firm
- IntegraDose Compounding Services LLC
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- MN
- Recall initiation date
- Jan 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2024