Medications & Supplements/Prescription Drugs

Medichem S.A.: Chlorhexidine Gluconate 20% Solution Recalled for Discoloration

Agency Publication Date: November 2, 2020

Summary

Medichem S.A. has recalled approximately 60,000 kilograms of Chlorhexidine Gluconate 20% solution due to reports of discoloration in the product. Chlorhexidine Gluconate is an antiseptic solution used in various medical and healthcare applications. This voluntary recall affects 12 specific batch numbers distributed in Alabama, New Jersey, and Texas. Consumers should not use the affected product and are advised to contact their healthcare provider or pharmacist for guidance on identifying and returning the product.

Risk

The discoloration indicates a potential change in the chemical stability or purity of the medication, which could reduce its effectiveness as an antiseptic or introduce unknown impurities during medical procedures.

What You Should Do

Check your product packaging for 'Chlorhexidine Gluconate 20% 0012 Medichem, S.A.' with NDC 53296-0012-0.
Verify if your product belongs to one of the following affected batches: A-200301, A-200307, A-200308, A-200309, A-200395, A-200488, A-200310, A-200311, A-200315, A-200319, A-200397, or A-200398.
Identify the specific lot number A-200301 which is confirmed to be part of this recall.
Immediately stop using any product from the affected batches and isolate it from your active supply.
Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and how it may impact your care.
Return any unused product to the place of purchase for a refund and contact Medichem S.A. at their Barcelona headquarters for further instructions if needed.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Product return and pharmacist consultation

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

Affected Products

Product: Chlorhexidine Gluconate 20% 0012 Medichem, S.A. (60,000 kg)

Model:

NDC 53296-0012-0

Recall #: D-0055-2021

Lot Numbers:

A-200301

A-200307

A-200308

A-200309

A-200395

A-200488

A-200310

A-200311

A-200315

A-200319

A-200397

A-200398

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86540

Status: Resolved

Manufacturer: Medichem S.A.

Sold By: Fructuos Gelabert 6-8

Manufactured In: Spain

Units Affected: 60,000 kg

Distributed To: Alabama, New Jersey, Texas

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 product packaging for 'Chlorhexidine Gluconate 20% 0012 Medichem, S.A.' with NDC 53296-0012-0.

Verify if your product belongs to one of the following affected batches: A-200301, A-200307, A-200308, A-200309, A-200395, A-200488, A-200310, A-200311, A-200315, A-200319, A-200397, or A-200398.

Identify the specific lot number A-200301 which is confirmed to be part of this recall.

Immediately stop using any product from the affected batches and isolate it from your active supply.

Contact your healthcare provider or pharmacist for guidance regarding the use of this medication and how it may impact your care.

Return any unused product to the place of purchase for a refund and contact Medichem S.A. at their Barcelona headquarters for further instructions if needed.

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