Vasostrict Injection
FDA Recall NDC 42023-237
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Vasostrict (NDC 42023-237). A significant event, classified as Class II, was initiated on Jan 11, 2024 by Par Health Usa, Llc. The reported reason for this action was: "Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Jan 11, 2024
Jan 24, 2024
1721 cartons
Recall Profile & Regulatory Data
Event ID
93805
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Par Sterile Products LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
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
Batch or Lot Expiration Information
Lot# 66702; Exp. 02/2025
Affected Packages Involved in this Recall
42023-164-01Product
42023-164-25Product
42023-164-10Product
42023-190-01Product
42023-219-01Product
42023-219-10Product
42023-237-01Product
42023-237-10Product
42023-268-01Product
42023-268-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
