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Blaine Labs Inc: Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs

DrugsSource: FDA (drug) · Date: 2026-07-08

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Blaine Labs Inc
Product
Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.
Reason / hazard
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Classification
Class I
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-04-08
Code info
Lot#: BL3608, Exp. 07/01/28.
Product quantity
1,171 - 1 oz bottles
Voluntary mandated
Voluntary: Firm initiated
City
Santa Fe Springs
State
CA
Country
United States
Event id
98731
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