Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
FDA Recall Z-1956-2025 · Posted 2025-06-11
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Recalling FirmContamac Solutions, Inc.
Recall StatusOpen, Classified
Product CodeMRC
Date Initiated2025-05-15
Product Quantity17,273 cartons (604,555 ampoules)
Reason for Recall
Contact lens insertion solution may lack sterility.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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