Drug Enforcement D-0461-2024

CGMP Deviations

Status

Terminated

Classification

Class II

Report Date

May 1, 2024

Termination Date

September 30, 2024

Product Information

Product description
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
Product quantity
10, 605 cartridges
Reason for recall
CGMP Deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide USA, Canada

Location & Firm

Recalling firm
HONEYWELL INC
Address
855 S Mint St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0461-2024
Event ID
94345
Recall initiation date
March 29, 2024
Center classification date
April 23, 2024
Code info
Manufacturer's Product Number/ Catalog Number: 32-002050-0000; Exp 06/21/2025
More code info
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