D-0699-2026 Class II Ongoing
FDA drug recall D-0699-2026 was initiated by Blaine Labs Inc on April 8, 2026 and is designated Class II. Reason for recall: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated The recall status is ongoing. Affected quantity: 5,555 bottles and tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2026
- Initiation Date
- April 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,555 bottles and tubes
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
Distribution Pattern
Nationwide in the USA
Code Information
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