FDA recall D-0258-2023

Frenda Corporation · Class II · drug

Product

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

Reason for recall

cGMP Deviations

Distribution

Puerto Rico

Key facts

Status: Terminated
Initiation date: 2022-12-15
Report date: 2023-02-08
Termination date: 2024-09-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Trujillo Alto, PR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0258-2023