Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.

FDA recall notice · announced February 22, 2023 · Consolidated Chemical

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.

Reason for recall

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot, expiry: Lot 3216, exp 04/23 and 3218, exp 10/23
Quantity: 3186 bottles
Status: Ongoing
Products in this recall event:
- Techni-Care Chloroxylenold 3%, [4 fl oz /118 mL or 8 fl oz/236 mL] per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. NDC 4 oz bottle: 46706-222-01; NDC 8 oz: 46706-222-02 (D-0325-2023)
- Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139. (D-0326-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.