Drug Enforcement D-0260-2023

cGMP Deviations

Status

Terminated

Classification

Class II

Report Date

February 8, 2023

Termination Date

September 10, 2024

Product Information

Product description
Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR
Product quantity
12,130 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-0260-2023
Event ID
91325
Recall initiation date
December 15, 2022
Center classification date
January 30, 2023
Code info
Lots: a) C012821, C012721, C021821;b) C012521, C021721; c) C021121, C022121
More code info
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