FDA recall D-0668-2022

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

Reason for recall

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

Distribution

Nationwide in 17 States to 45 doctors.

Key facts

Status

Terminated

Initiation date

2022-01-25

Report date

2022-03-30

Termination date

2022-08-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Fe Springs, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0668-2022