Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution

FDA device recall Z-1956-2025 · posted 2025-06-11 · Open, Classified

Recall details

Recalling firm

Contamac Solutions, Inc.

Reason for recall

Contact lens insertion solution may lack sterility.

Action taken

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 recall@contamacsolutions.com to initiate a return. 4. Complete the Customer Response form. If you are having trouble accessing the form, please reach out to recall@contamacsolutions.com 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.

Root cause

Process control

Status

Open, Classified

Product code

MRC

Quantity affected

17,273 cartons (604,555 ampoules)

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.

Date initiated

2025-05-15

Date posted

2025-06-11

Location

Grand Junction, CO

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