Vasopressin Syringes Recalled for Subpotency by IntegraDose Compounding Services
IntegraDose Compounding Services recalled 281 syringes of Vasopressin 2 Unit/2 mL due to subpotency. The voluntary recall affects Lot #20230921VAS-2 distributed in Minnesota.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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) due to subpotency. Although no illnesses or injuries have been reported, a subpotent vasopressor represents a risk-of-harm situation, as patients who receive these doses may not obtain the intended therapeutic effect.
Plain-English summary
IntegraDose Compounding Services LLC recalled 281 syringes of Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride. The recalled product is Lot #20230921VAS-2 (expiration date March 19, 2024, NDC 71139-0190-1), manufactured at 719 Kasota Ave SE, Minneapolis, Minnesota.
The recall was initiated because the drug is subpotent—the vasopressin concentration in the syringes is lower than the labeled amount. The manufacturer voluntarily identified and reported this issue to the FDA on January 31, 2024. The FDA classified this as a Class II recall on January 22, 2024.
The affected syringes were distributed only in Minnesota. The status of this recall is listed as ongoing.
The recalled product
- 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
- Manufacturer
- IntegraDose Compounding Services LLC
- Category
- Drug — Injectable / Vasopressor
- Hazard
- Affected units
- 281
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 (2)
- Lot #: 20230921VAS-2
- Exp. Date 03/19/2024
Distribution
Distributed in 1 state:
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