Warning
Blaine Labs Inc Recalls Revitaderm Wound Care
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0699-2026Drug / Pharmaceutical
Blaine Labs Inc Recalls Revitaderm Wound Care
Blaine Labs Inc · Class II — Moderate Risk
Product Description
Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,
Reason for Recall
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Blaine Labs Inc has recalled a pharmaceutical product that the FDA classified as Class II affecting 5,555 bottles and tubes. The recall was initiated on April 8, 2026. CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated. It was distributed nationwide. Class II recalls involve products that might cause a temporary health problem or pose only a slight threat of a serious nature. Consumers should discontinue use and contact the firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.