Blaine Labs Inc recalls REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 2

Recalled March 30, 2022 · FDA recall D-0668-2022 · Blaine Labs

Hazard

Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus. · FDA Class I

Units

1119 (1 oz.) bottles/ 772 (3 oz.) tubes

Sold at

Nationwide in 17 States to 45 doctors.

Description

Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.

Product

REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670

Manufacturer(s)

Blaine Labs Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →