Reported Mar 30, 2022 · Terminated
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in…
Blaine Labs Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Blaine Labs Inc · 11037 Lockport Pl · Santa Fe Springs, CA · 90670-4634
Is this the product you have?
- 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
- Lot codes and dates
Lot/Batch #: BL 2844Expiration date 2/19/2023
- Amount recalled
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Using this product could cause serious injury, illness or death — stop using it now.
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