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Class II: temporary or reversible health riskOngoing

Par Sterile Products Vasostrict Recall

Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0

Par Sterile Products LLC · Rochester, MI

Risk level
Class II
Reported by FDA
Jan 24, 2024
Recall ID
D-0232-2024
Check your lot numberHow we source this data

Summary

Par Sterile Products recalled Vasostrict starting Jan 11, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0232-2024 on Jan 24, 2024. Reason: Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit. Status: Ongoing.

Why it was recalled

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

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 numbers, UPCs & expiration codes

Lot # 66702; Exp. 02/2025

Where it was sold

Nationwide USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0232-2024
Classification
Class II
Status
Ongoing
Recall initiated
Jan 11, 2024
FDA report date
Jan 24, 2024
Quantity
1721 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Par Sterile Products LLC

Original FDA data

Every field from FDA enforcement report D-0232-2024, exactly as published.

Show all FDA fields
City
Rochester
State
MI
Status
Ongoing
Country
United States
Event ID
93805
Address
870 Parkdale Rd
Code information
Lot # 66702; Exp. 02/2025
Postal code
48307-1740
Report date
Jan 24, 2024
Product type
Drugs
Recall number
D-0232-2024
Classification
Class II
Recalling firm
Par Sterile Products LLC
Product quantity
1721 cartons
Reason for recall
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide USA
Recall initiation date
Jan 11, 2024
Initial firm notification
Letter
Center classification date
Jan 16, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0232-2024, published Jan 24, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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