Drug Enforcement D-1089-2023

CGMP Deviations

Status

Terminated

Classification

Class II

Report Date

August 30, 2023

Termination Date

June 3, 2024

Product Information

Product description
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
Product quantity
9
Reason for recall
CGMP Deviations
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide within the United States, Singapore, Korea and Hong Kong

Location & Firm

Recalling firm
Parker Laboratories, Inc.
Address
286 Eldridge Rd, N/A

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

Codes & Dates

Recall number
D-1089-2023
Event ID
92786
Recall initiation date
August 2, 2023
Center classification date
August 18, 2023
Code info
Lot #: a) G0323002, Exp. Date 3/1/2025 Lot #: b) G1122001, Exp. Date 11/15/2024
More code info
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