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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Vasostrict Injection Recalled Due to Superpotency Risk

Agency Publication Date: January 16, 2024
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Summary

Par Sterile Products LLC is recalling 1,721 cartons of Vasostrict (vasopressin in 5% Dextrose) Injection because the medication may be superpotent, meaning it contains more of the active ingredient than specified. Testing at the 3-month and 6-month stability intervals revealed that the drug exceeded its potency limits. No incidents or injuries have been reported to date, but the manufacturer is voluntarily recalling the affected batch to ensure patient safety.

Risk

A superpotent medication provides a higher dose than intended by the healthcare provider, which can lead to serious adverse clinical effects or toxicity. Because this drug is administered intravenously in critical care settings, receiving an incorrect dose poses a medium risk to patient health.

What You Should Do

  1. This recall affects Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), sold in cartons of 10 single-dose vials (100 mL each).
  2. Identify affected products by checking for Lot # 66702 with an expiration date of 02/2025 and NDC 42023-237-10.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer, Par Sterile Products LLC, or your distributor to arrange for the return of any remaining inventory from this lot.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Vasostrict (vasopressin in 5% Dextrose) Injection
Variants: 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
Lot Numbers:
66702 (Exp. 02/2025)
NDC:
42023-237-10

Recall #: D-0232-2024; Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93805
Status: Active
Manufacturer: Par Sterile Products LLC
Sold By: Par Pharmaceutical
Manufactured In: United States
Units Affected: 1721 cartons
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.