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Recall Observatory FDA recall evidence

Drug product

Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning Solutions LLC, 7001 W Arby Ave Suite 100, Las Vegas, NV 89113, UPC#: 8 60001 93396 3

D-0018-2022

September 21, 2021

Class II

Product summary

Firm
Sanitor Corporation
Event
Event 88754
Status
Terminated
Classification
Class II
Quantity
unknown
Official record key
drug-enforcement:D-0018-2022

Official wording

Reason: CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.

Code information: Lot # 20102, 20103, Exp, Sept, 2021;

Distribution pattern: Distributed to one distributor located in Las Vegas, NV.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations