Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, l
Summary
The FDA issued a Class II for Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) pac by Blaine Labs Inc. Reason: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated.
Details
Source
Drug Recall
External ID
D-0699-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
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,
Lot/Code Info: Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27
Quantity Affected: 5,555 bottles and tubes
Reason for Recall
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-08
Company
Santa Fe Springs, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 48 drug recalls issued in the same week, part of 93 drug-related FDA actions this month.
Blaine Labs Inc has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Blaine Labs Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blaine Labs Inc have FDA actions?
Blaine Labs Inc has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0699-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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