Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe,
Summary
The FDA issued a Class II for Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, by IntegraDose Compounding Services LLC. Reason: Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date..
Details
Source
Drug Recall
External ID
D-0325-2024
Action Date
2024-02-21
Status
Ongoing
Category
drug
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/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
Quantity Affected: 1,299 syringes
Reason for Recall
Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.
Distribution
MN
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-22
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 61 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-0325-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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