Blaine Labs Inc: Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) Packaged As (a) 1.0 Fl Oz (16 Ml) Bottle, Long Pointy Cap

Recalling firm
Blaine Labs Inc
Product
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
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-04-08
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/9a058a95-dd96-4677-8591-137b483392a4