Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as…
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Official FDA data recordWhat to do
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- 1Compare the product, size and lot or date code with this notice.
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What the notice says
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated.
Recall details
- Firm
- Blaine Labs Inc
- Status
- Ongoing
- Reported
- Jul 8, 2026
- Started
- Apr 8, 2026
- Where sold
- Nationwide in the USA
- Quantity
- 5,555 bottles and tubes
- Notice number
- D-0697-2026
Lots, UPC, dates
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
Agency wording
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,
Source: FDA OTC report. This is not medical advice. Compare your package codes before you act.