Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per… recall
FDA recall D-0461-2024 · initiated Mar 29, 2024
HONEYWELL INC recalled Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.… in Mar 2024 — an FDA Class II recall (D-0461-2024) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10, 605 cartridges
Details
- Product
- Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37
- Recalling company
- HONEYWELL INC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide USA, Canada
- Initiated
- Mar 29, 2024
- FDA report date
- May 1, 2024
Frequently asked
- Was Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.… recalled?
- HONEYWELL INC recalled Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.… in Mar 2024 — an FDA Class II recall (D-0461-2024) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.… recalled?
- Per the FDA enforcement record, the reason for recall D-0461-2024 was: CGMP Deviations
- Is a recalled Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.… are affected?
- Distributed: Nationwide USA, Canada. The recall covers these lots — Manufacturer's Product Number/ Catalog Number: 32-002050-0000; Exp 06/21/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0461-2024.