Medications & Supplements/Topical Products

Care-Tech Techni-Care and Humatrix Products Recalled for Manufacturing Issues

Agency Publication Date: February 15, 2023

Summary

Consolidated Chemical, Inc. is recalling Techni-Care Chloroxylenold 3% and Humatrix Microclysmic Gel produced by Care-Tech Laboratories. Approximately 3,190 units are affected by this recall, which was initiated because the products were not manufactured in compliance with Current Good Manufacturing Practice (CGMP) standards. These violations mean the safety, quality, and purity of the products cannot be guaranteed.

Risk

Failure to follow mandatory manufacturing standards can result in products that are contaminated or do not have the correct strength of active ingredients. This poses a risk of infection or skin irritation, and the products may not work as intended for medical or antiseptic purposes.

What You Should Do

This recall involves Techni-Care Chloroxylenold 3% (4 oz and 8 oz bottles) and Humatrix Microclysmic Gel (8 oz bottles) sold under the Care-Tech Laboratories brand.
Check your product for Techni-Care NDC numbers 46706-222-01 (4 oz) or 46706-222-02 (8 oz) with lot numbers 3217A or 3217B and an expiration date of 06/23.
Check your Humatrix Microclysmic Gel bottles for lot numbers 3216 (Exp 04/23) or 3218 (Exp 10/23).
If you have health concerns related to the use of these products, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Consolidated Chemical, Inc. for further instructions.
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

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: Techni-Care Chloroxylenold 3%by Care-Tech Laboratories, Inc.

Variants: 4 fl oz / 118 mL, 8 fl oz / 236 mL

Lot Numbers:

3217A (Exp 06/23)

3217B (Exp 06/23)

NDC:

46706-222-01

46706-222-02

Manufactured by Care-Tech Laboratories, Inc.

Product: Humatrix Microclysmic Gelby Care-Tech Laboratories, Inc.

Variants: 8 oz bottle

Lot Numbers:

3216 (Exp 04/23)

3218 (Exp 10/23)

Manufactured by Care-Tech Laboratories, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91521

Status: Active

Manufacturer: Consolidated Chemical, Inc

Sold By: Retail pharmacies; Medical supply distributors

Manufactured In: United States

Units Affected: 2 products (4 oz: 6580 bottles; 8 oz: 1248 bottles; 3186 bottles)

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 involves Techni-Care Chloroxylenold 3% (4 oz and 8 oz bottles) and Humatrix Microclysmic Gel (8 oz bottles) sold under the Care-Tech Laboratories brand.

Check your product for Techni-Care NDC numbers 46706-222-01 (4 oz) or 46706-222-02 (8 oz) with lot numbers 3217A or 3217B and an expiration date of 06/23.

Check your Humatrix Microclysmic Gel bottles for lot numbers 3216 (Exp 04/23) or 3218 (Exp 10/23).

If you have health concerns related to the use of these products, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact Consolidated Chemical, Inc. for further instructions.

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

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: Techni-Care Chloroxylenold 3%by Care-Tech Laboratories, Inc.

Variants: 4 fl oz / 118 mL, 8 fl oz / 236 mL

Lot Numbers:

3217A (Exp 06/23)

3217B (Exp 06/23)

NDC:

46706-222-01

46706-222-02

Manufactured by Care-Tech Laboratories, Inc.

Product: Humatrix Microclysmic Gelby Care-Tech Laboratories, Inc.

Variants: 8 oz bottle

Lot Numbers:

3216 (Exp 04/23)

3218 (Exp 10/23)

Manufactured by Care-Tech Laboratories, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91521

Status: Active

Manufacturer: Consolidated Chemical, Inc

Sold By: Retail pharmacies; Medical supply distributors

Manufactured In: United States

Units Affected: 2 products (4 oz: 6580 bottles; 8 oz: 1248 bottles; 3186 bottles)

Distributed To: Nationwide