Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 7113
Summary
The FDA issued a Class II for Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 by IntegraDose Compounding Services LLC. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0258-2024
Action Date
2024-01-31
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 20230921VAS-2, Exp. Date 03/19/2024
Quantity Affected: 281 syringes
Reason for Recall
Subpotent Drug
Distribution
MN only
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-12
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 60 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
IntegraDose Compounding Services LLC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IntegraDose Compounding Services LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IntegraDose Compounding Services LLC have FDA actions?
IntegraDose Compounding Services LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0258-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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