FDA Recall Open, Classified

Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution

Recall: Z-1956-2025 · Initiated May 15, 2025

Recall

Recall Number
Z-1956-2025
Event Number
96900
Firm
Contamac Solutions, Inc.
FEI Number
3016114779
Product Code
MRC
Status
Open, Classified
Root Cause
Process control
Initiated
May 15, 2025
Posted
June 11, 2025
Address
806 Kimball Ave, Grand Junction, CO, 81501-3842

Description

Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution

Reason

Contact lens insertion solution may lack sterility.

Action

On May 15, 2025, Contamac Solutions issued a Urgent Medical Device Recall Notification via Email. In addition, the firm issued a press release concerning the recall on the Contamac Solutions, Inc. eCommerce website . Contamac Solutions ask consignees to take the following actions: 1. Refer to the package label and Product Distribution Information to verify the product is impacted. 2. Immediately quarantine and discontinue use of impacted product 3. Please either return any unused product to Contamac Solutions or destroy and discard the product (i.e. remove vial cap and empty contents before discarding). Please contact [email protected] to initiate a return. 4. Complete the Customer Response form. If you are having trouble accessing the form, please reach out to [email protected] for assistance. 5. Provide the recall notification to all those who need to be aware, including others within your organization or to any organization where the affected devices may have been transferred. 6. Distributors - If you have further distributed the product, please provide this recall notification to those distributors and ask them to provide a copy to their customer.

Distribution

US Nationwide distribution in the states of AZ, CA, CO, FL, IL, IN, KS, KY, LA, ME, MI, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TX, UT, VA, WA, WI.

Quantity

17,273 cartons (604,555 ampoules)