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Recall Observatory FDA recall evidence

Drug product

Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and b)18 fl. oz./550 ml Pump Bottles (NDC 30775-040-18), Parker Laboratories, Inc. 286 Eldridge Road, Fairfield, NJ 07004

D-1089-2023

August 02, 2023

Class II

Product summary

Firm
Parker Laboratories, Inc.
Event
Event 92786
Status
Terminated
Classification
Class II
Quantity
9
Official record key
drug-enforcement:D-1089-2023

Official wording

Reason: CGMP Deviations

Code information: Lot #: a) G0323002, Exp. Date 3/1/2025 Lot #: b) G1122001, Exp. Date 11/15/2024

Distribution pattern: Nationwide within the United States, Singapore, Korea and Hong Kong

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations