Drug Enforcement D-0258-2023

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

February 8, 2023

Termination Date

September 10, 2024

Product Information

Product description
Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976
Product quantity
44,140 bottles
Reason for recall
cGMP Deviations
Recall initiation reason
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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-0258-2023
Event ID
91325
Recall initiation date
December 15, 2022
Center classification date
January 30, 2023
Code info
Lots: a) C030121, C021121, C021021, C030121, C030221, C021721; b) C012721, C012621, C012521, C021721; c) C042721
More code info
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