Revitaderm Wound Care Gel
FDA Recall NDC 63347-120
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Revitaderm Wound Care (NDC 63347-120). A significant event, classified as Class I, was initiated on Jan 25, 2022 by Blaine Labs Inc.. The reported reason for this action was: "Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
January 2022 Class I Recall: Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Recall Number
Class I Terminated
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Jan 25, 2022
Mar 30, 2022
1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Recall Profile & Regulatory Data
Event ID
89481
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Blaine Labs Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in 17 States to 45 doctors.
Termination Date
Aug 01, 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
Batch or Lot Expiration Information
Lot# Lot/
Lot# : BL 2844, Expiration date 2/19/2023
Affected Packages Involved in this Recall
63347-120-01Product
63347-120-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
