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
Reported: March 30, 2022 Initiated: January 25, 2022 #D-0668-2022
Product Description
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.
Details
- Recalling Firm
- Blaine Labs Inc
- Units Affected
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
- Distribution
- Nationwide in 17 States to 45 doctors.
- Location
- Santa Fe Springs, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Blaine Labs Inc. Units affected: 1119 (1 oz.) bottles/ 772 (3 oz.) tubes.
Why was this product recalled? ▼
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 30, 2022. Severity: Critical. Recall number: D-0668-2022.
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