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BENZALKONIUM CHLORIDE Recall D-0668-2022

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

BENZALKONIUM CHLORIDE Recall D-0668-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0668-2022
Event ID89481
BrandREVITADERM WOUND CARE
Generic NameBENZALKONIUM CHLORIDE
ManufacturerBENZALKONIUM CHLORIDE
Original Package?1
Active SubstanceBENZALKONIUM CHLORIDE
Drug RouteTOPICAL
DistributionNationwide in 17 States to 45 doctors.
Quantity1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Recall ReasonMicrobial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Drug ClassificationClass I
Drug Code Info20220330
Product NDC63347-120
Recall Initiation Date20220125
Report Date20220330
Classification Date20220318
Address11037 Lockport Pl
Santa Fe Springs, CA 90670-4634
United States
Recalling FirmBlaine Labs Inc
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Unique Ingredient IdentifierF5UM2KM3W7
Drug Application Numberpart333A
Structured Product Labeling (SPL ID)bd77ff71-06a1-46e7-946b-2e0336716538
Structured Product Labeling (SPL Set ID)9254dada-4e32-43a0-892b-c488d68e23e7
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