Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials
Summary
The FDA issued a Class II for Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 unit by Par Sterile Products LLC. Reason: Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit..
Details
Source
Drug Recall
External ID
D-0232-2024
Action Date
2024-01-24
Status
Ongoing
Category
drug
Product Description
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
Lot/Code Info: Lot # 66702; Exp. 02/2025
Quantity Affected: 1721 cartons
Reason for Recall
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-11
Company
Rochester, MI
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 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Par Sterile Products LLC has 3 FDA actions in our database, including 3 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 (Par Sterile Products LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Par Sterile Products LLC have FDA actions?
Par Sterile Products LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0232-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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