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

FDA recall notice · announced March 30, 2022 · Blaine Labs

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide in 17 States to 45 doctors.
Lot/code information: Lot/Batch #: BL 2844, Expiration date 2/19/2023
Quantity: 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Status: Terminated
Products in this recall event:
- 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 (D-0668-2022)

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