Z-1956-2025Class II

Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution

Name: Z-1956-2025 Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Creator: Contamac Solutions, Inc.
Published: 2025-05-15
License: https://open.fda.gov/license/

Contamac Solutions, Inc. / initiated 2025-05-15 / Open, Classified / root cause: manufacturing process

FDA source

Contamac Solutions, Inc. began a recall of Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution on 2025-05-15. FDA classified it as Class II and gives the reason as "Contact lens insertion solution may lack sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1956-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-15
Posted: 2025-06-11
Recalling firm: Contamac Solutions, Inc.
Product: Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Product code: MRC Products, Contact Lens Care, Rigid Gas Permeable
Reason for recall: Contact lens insertion solution may lack sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 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.
Product codes and lots: UDI: 00850012123002/ Lot: HFH, HGC, HGI, HGN, HKF, HKK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1956-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1956-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-11

Product code MRC

K181566Class IINutrifillContamac, Ltd. / cleared 2018-10-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)