IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Made in China, Distrib...
FDA Recall #D-0241-2021 — Class II — December 23, 2020
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.
Recalling Firm
Shane Erickson Inc — Spring Park, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
29,376 bottles
Distribution
Nationwide USA and Canada
Code Information
Lot: 2020/05/11, exp 2023/05/10
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated