FDA-Drug2022-03-30Class I
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
Blaine Labs Inc
Hazard
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Sold states
Nationwide in 17 States to 45 doctors.
Affected count
1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Manufactured in
11037 Lockport Pl, N/A, Santa Fe Springs, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0668-2022Don't want to check this manually?
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