Drug Enforcement D-0090-2025

cGMP Deviations: Out of specification results for micro in hand soap products.

Status

Ongoing

Classification

Class II

Report Date

December 11, 2024

Termination Date

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Product Information

Product description
ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
Product quantity
—
Reason for recall
cGMP Deviations: Out of specification results for micro in hand soap products.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Midlab Incorporated
Address
140 Private Brand Way

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

Codes & Dates

Recall number
D-0090-2025
Event ID
95826
Recall initiation date
November 6, 2024
Center classification date
December 2, 2024
Code info
Lot 0711241
More code info
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