Drug Enforcement D-0254-2023

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

February 8, 2023

Termination Date

September 10, 2024

Product Information

Product description
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9
Product quantity
144 bottles
Reason for recall
cGMP Deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Puerto Rico

Location & Firm

Recalling firm
Frenda Corporation
Address
Calle A Lote 7 Parque Ind Las Cuevas, N/A

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

Codes & Dates

Recall number
D-0254-2023
Event ID
91325
Recall initiation date
December 15, 2022
Center classification date
January 30, 2023
Code info
Lot: C013121
More code info
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