FDA Enforcement
Class II
Ongoing
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Recall: Z-1956-2025
·
Reported June 18, 2025
Enforcement
- Recall Number
- Z-1956-2025
- Event ID
- 96900
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Contamac Solutions, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- June 18, 2025
- Initiation Date
- May 15, 2025
- Classification Date
- June 11, 2025
- Address
- 806 Kimball Ave, Grand Junction, CO, 81501-3842, United States
Description
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Reason
Contact lens insertion solution may lack sterility.
Code Info
UDI: 00850012123002/ Lot: HFH, HGC, HGI, HGN, HKF, HKK
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)