FDA Recall Open, Classified

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

Recall: Z-2400-2026 · Initiated May 27, 2026

Recall

Recall Number
Z-2400-2026
Event Number
99105
Firm
Inter-Med Llc
FEI Number
3000209941
Product Code
MVL
Status
Open, Classified
Root Cause
Labeling mix-ups
Initiated
May 27, 2026
Posted
June 10, 2026
Address
2200 South St, Racine, WI, 53404-1510

Description

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

Reason

Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.

Action

On 5/27/2026, firm notified consignees via email. Consignees were instructed to return all units from Lot 2026-0204 to Inter-Med, Inc. Inter-Med, Inc. will provide prepaid return shipping labels. All returned product will be replaced with correctly packaged product at no charge, or a credit may be issued at the customer's preference. Customers must also notify any downstream dental practices or end users who received product from this lot and instruct them to return product.

Distribution

US Nationwide distribution in the states of Tennessee and Missouri.

Quantity

500