D-0241-2021 Class II Terminated

Recalled by Shane Erickson Inc — Spring Park, MN

Recall Details

Product Type
Drugs
Report Date
February 3, 2021
Initiation Date
December 23, 2020
Termination Date
September 29, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29,376 bottles

Product Description

IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as Thrifty White Pharmacy Wash-Free Hand Sanitizer. UPC 8 19845 00599 2

Reason for Recall

CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.

Distribution Pattern

Nationwide USA and Canada

Code Information

Lot: 2020/05/11, exp 2023/05/10