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Recall Observatory FDA recall evidence

Drug 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

D-0461-2024

March 29, 2024

Class II

Product summary

Firm
HONEYWELL INC
Event
Event 94345
Status
Terminated
Classification
Class II
Quantity
10, 605 cartridges
Official record key
drug-enforcement:D-0461-2024

Official wording

Reason: CGMP Deviations

Code information: Manufacturer's Product Number/ Catalog Number: 32-002050-0000; Exp 06/21/2025

Distribution pattern: Nationwide USA, Canada

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations