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Recall Observatory FDA recall evidence

Drug product

Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85

D-0361-2021

March 29, 2021

Class II

Product summary

Firm
Spartan Chemical Co Inc
Event
Event 87633
Status
Terminated
Classification
Class II
Quantity
400 containers
Official record key
drug-enforcement:D-0361-2021

Official wording

Reason: CGMP Deviations

Code information: Lot, expiry: Lot 538885, exp 1/25/2023

Distribution pattern: Nationwide USA and Puerto Rico; Mexico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations