Medications & Supplements/Prescription Drugs

AuroMedics Pharma LLC: Vancomycin Hydrochloride Injection Recalled Due to Product Discoloration

Agency Publication Date: December 6, 2019

Summary

AuroMedics Pharma LLC is recalling approximately 275,060 vials of Vancomycin Hydrochloride for Injection, USP (1 g per vial) because the liquid can become discolored after it is mixed for use. Vancomycin is an antibiotic used to treat serious bacterial infections. This recall was initiated after reports of the product changing color, which indicates a potential quality or safety issue with the medication.

Risk

Using discolored medication can mean the drug has degraded or is contaminated, which may lead to reduced effectiveness in treating an infection or cause adverse physical reactions when injected.

What You Should Do

Check your medication vials for Vancomycin Hydrochloride for Injection, USP (1 g per vial) with NDC 55150-204-20.
Locate the lot number and expiration date on the vial label to see if it matches any of the affected lots: CVM180003 or CVM180004 (Exp 04/2020); CVM180008 (Exp 07/2020); or CVM180009, CVM180010, CVM180011, and CVM180012 (Exp 09/2020).
If your medication is from an affected lot, do not use it if you notice any unusual discoloration after it has been reconstituted.
Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and for guidance on returning the product.
Return any unused vials to the pharmacy where they were purchased for a refund and contact AuroMedics Pharma LLC at 1-888-238-7880 for further instructions.
Report any adverse reactions or quality problems to the FDA's MedWatch program at 1-800-332-1088 or through their website.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare consultation and refund

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

Affected Products

Product: Vancomycin Hydrochloride for Injection, USP (1 g per vial)

Model:

NDC 55150-204-20

Lot Numbers:

CVM180003 (Exp 04/2020)

CVM180004 (Exp 04/2020)

CVM180008 (Exp 07/2020)

CVM180009 (Exp 09/2020)

CVM180010 (Exp 09/2020)

CVM180011 (Exp 09/2020)

CVM180012 (Exp 09/2020)

Date Ranges: Expiration 04/2020, Expiration 07/2020, Expiration 09/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84356

Status: Resolved

Manufacturer: AuroMedics Pharma LLC

Sold By: hospitals; pharmacies; clinics

Manufactured In: India, United States

Units Affected: 275,060 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 medication vials for Vancomycin Hydrochloride for Injection, USP (1 g per vial) with NDC 55150-204-20.

Locate the lot number and expiration date on the vial label to see if it matches any of the affected lots: CVM180003 or CVM180004 (Exp 04/2020); CVM180008 (Exp 07/2020); or CVM180009, CVM180010, CVM180011, and CVM180012 (Exp 09/2020).

If your medication is from an affected lot, do not use it if you notice any unusual discoloration after it has been reconstituted.

Contact your healthcare provider or pharmacist immediately to discuss alternative treatments and for guidance on returning the product.

Return any unused vials to the pharmacy where they were purchased for a refund and contact AuroMedics Pharma LLC at 1-888-238-7880 for further instructions.

Report any adverse reactions or quality problems to the FDA's MedWatch program at 1-800-332-1088 or through their website.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).