Drug Enforcement D-0257-2023

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

February 8, 2023

Termination Date

September 10, 2024

Product Information

Product description
Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976
Product quantity
65,376 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-0257-2023
Event ID
91325
Recall initiation date
December 15, 2022
Center classification date
January 30, 2023
Code info
Lots: a)C011721, C011421, C021721, C021521, C021421, C060321, C060221, C042821, C042721, C022521 , C011321; b) C011821, C011721, C052521, C051921, C052421, C030121, C022821
More code info