Medications & Supplements/Topical Products

Revitaderm Wound Care Gel Recalled for Bacillus Cereus Contamination

Agency Publication Date: March 18, 2022

Summary

Blaine Labs Inc. has recalled 1,119 bottles (1 oz.) and 772 tubes (3 oz.) of Revitaderm Wound Care Gel (benzalkonium chloride) because the product was found to be contaminated with Bacillus cereus bacteria. The gel was distributed nationwide across 17 states to 45 doctors' offices and medical clinics. No injuries or incidents have been reported to date.

Risk

The product is contaminated with Bacillus cereus, which can cause serious skin and soft tissue infections. This poses a critical risk particularly to patients with weakened immune systems or those applying the gel to open wounds.

What You Should Do

This recall affects Revitaderm Wound Care Gel (0.1% Benzalkonium Chloride) packaged in 29.6 mL (1.0 FL OZ) bottles and 88.7 mL (3.0 FL OZ) tubes.
Check your product packaging for lot number BL 2844 with an expiration date of 2/19/2023. Affected bottles carry NDC 63347-120-02 and affected tubes carry NDC 63347-120-01.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or need to report a problem.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: REVITADERM WOUND CARE GEL

Variants: 29.6 mL (1.0 FL OZ) bottles, 88.7 mL (3.0 FL OZ) tubes

Lot Numbers:

BL 2844 (Exp 2/19/2023)

NDC:

63347-120-02

63347-120-01

Benzalkonium Chloride 0.1% in a gel containing transforming growth factor-b.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89481

Status: Resolved

Manufacturer: Blaine Labs Inc

Sold By: Doctors' offices; Medical clinics

Manufactured In: United States

Units Affected: 1119 (1 oz.) bottles/ 772 (3 oz.) tubes

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

This recall affects Revitaderm Wound Care Gel (0.1% Benzalkonium Chloride) packaged in 29.6 mL (1.0 FL OZ) bottles and 88.7 mL (3.0 FL OZ) tubes.

Check your product packaging for lot number BL 2844 with an expiration date of 2/19/2023. Affected bottles carry NDC 63347-120-02 and affected tubes carry NDC 63347-120-01.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or need to report a problem.