Vasopressin Compounded Injectable Syringes Recalled for Sub-Potency Failure
IntegraDose Compounding Services is recalling Vasopressin injectable syringes because the medication may lose potency before its labeled expiration date, potentially leaving patients with reduced doses.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical medication (vasopressin) with sub-potency issues and no reported illnesses or hospitalizations. It meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' warranting High severity.
Plain-English summary
IntegraDose Compounding Services LLC is recalling Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection. The recalled syringes are pre-filled, compounded injectable products with a concentration of 1 Unit/mL, distributed in Minnesota. A total of 1,299 syringes have been recalled.
The FDA identified that these compounded syringes fail to maintain their labeled potency through the duration of the labeled expiration date and beyond-use date. This means the medication's effectiveness may degrade before healthcare providers and patients expect it to, potentially rendering doses less effective than prescribed.
The affected lots are: Lot #20230929VAS-2 (Exp. 02/29/2024), Lot #20231004VAS-2 (Exp. 04/01/2024), Lot #20231010VAS-2 (Exp. 04/07/2024), and Lot #20231013VAS-2 (Exp. 04/10/2024). These compounded syringes were distributed for medical office and professional use.
Healthcare providers and patients who have received this product should verify lot numbers and expiration dates against the affected list. If you have one of the affected lots, do not use the product and contact IntegraDose Compounding Services LLC or your healthcare provider for replacement or disposal instructions.
The recalled product
- 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.
- Manufacturer
- IntegraDose Compounding Services LLC
- Category
- Drug — Injectable / Compounded
- Hazard
- sub-potency
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distribution
Distributed in 1 state:
- MN
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