FDAFDA · Food and drugs·Recall number D-0668-2022
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
Published March 30, 2022 · Recall initiated: January 25, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- REVITADERM WOUND CARE
- Manufacturer
- Blaine Labs Inc
- Distributor
- Nationwide in 17 States to 45 doctors.
- Lot
- Lot/Batch #: BL 2844, Expiration date 2/19/2023
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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