Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Summary
The FDA issued a Class II for Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution by Contamac Solutions, Inc.. Reason: Contact lens insertion solution may lack sterility..
Details
Source
Device Recall
External ID
Z-1956-2025
Action Date
2025-06-18
Status
Ongoing
Category
device
Product Description
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Lot/Code Info: UDI: 00850012123002/ Lot: HFH, HGC, HGI, HGN, HKF, HKK
Quantity Affected: 17,273 cartons (604,555 ampoules)
Reason for Recall
Contact lens insertion solution may lack sterility.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-15
Company
Grand Junction, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Contamac Solutions, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Contamac Solutions, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Contamac Solutions, Inc. have FDA actions?
Contamac Solutions, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1956-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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