Shane Erickson Inc: Drug Recall

Recall #D-0239-2021 · 12/23/2020

Class II: Risk

Recall Details

Recall Number
D-0239-2021
Classification
Class II
Product Type
Drug
Recalling Firm
Shane Erickson Inc
Status
Terminated
Date Initiated
12/23/2020
Location
Spring Park, MN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36,505 bottles

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.

Product Description

IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, Made in China, ALSO distributed with Custom front labels as follows a) Sadie G. Mays Health & Rehabilitation Center, b) Pacers logo, c) northwood CHURCH, d) ROGERTHEROOFER.com and e) SoFi Stadium Wash-Free Hand Sanitizer. UPC 8 19845 00597 8

Distribution Pattern

Nationwide USA and Canada

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.