Medications & Supplements/Prescription Drugs

Mylan Institutional LLC: Aloprim (allopurinol sodium) Injection Recalled for Discoloration

Agency Publication Date: May 20, 2020

Summary

Mylan Institutional LLC is recalling approximately 3,010 vials of Aloprim (allopurinol sodium) for Injection, 500 mg. The recall was initiated because routine stability testing revealed that the medication's appearance and solution color changed as it approached the end of its shelf life. This discoloration indicates that the drug may no longer meet established quality and potency standards.

Risk

The change in color and appearance indicates the medication may be chemically unstable or degrading. Using discolored injectable medication could lead to reduced effectiveness of the treatment or cause unexpected adverse health reactions in patients.

What You Should Do

Check your medical supplies or pharmacy stock for Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vials with NDC 67457-187-50.
Identify if your product matches Lot N1700771 (Expiration: October 2020) or Lot N1800127 (Expiration: February 2021).
Immediately stop using and quarantine any vials from these specific lots to ensure they are not administered to patients.
Contact your healthcare provider or pharmacist if you have concerns about previous treatments or if you need to arrange for a replacement supply.
Return any unused product from the affected lots to the place of purchase for a refund and contact Mylan Institutional LLC for specific return instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report any adverse events related to this recall.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial

Model:

NDC: 67457-187-50

Recall #: D-1271-2020

Lot Numbers:

N1700771 (Exp October 2020)

N1800127 (Exp February 2021)

Date Ranges: October 2020, February 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85624

Status: Resolved

Manufacturer: Mylan Institutional LLC

Sold By: Hospitals; Clinics; Pharmacies

Manufactured In: United States

Units Affected: 3,010 vials

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 · 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.

Summary

What You Should Do

Check your medical supplies or pharmacy stock for Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vials with NDC 67457-187-50.

Identify if your product matches Lot N1700771 (Expiration: October 2020) or Lot N1800127 (Expiration: February 2021).

Immediately stop using and quarantine any vials from these specific lots to ensure they are not administered to patients.

Contact your healthcare provider or pharmacist if you have concerns about previous treatments or if you need to arrange for a replacement supply.

Return any unused product from the affected lots to the place of purchase for a refund and contact Mylan Institutional LLC for specific return instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report any adverse events related to this recall.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.