CLASS II Drug recall · Reported 3 Feb 2021 · FDA Enforcement Report
IMC Wash-Free Hand Sanitizer, (ethyl alcohol) recalled by Shane Erickson
Shane Erickson is recalling IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, distributed nationwide in the US. The recall was initiated on 23 Dec 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0240-2021
- FDA event ID
- 87037
- Recalling firm
- Shane Erickson, Spring Park, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2020
- FDA classified
- 22 Jan 2021
- Reported
- 3 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Potency & Assay
- Drug class
- Hand Sanitizer
Timeline
| 23 Dec 2020 | Recall initiated by company | |
| 22 Jan 2021 | Classified by FDA | +30 days |
| 3 Feb 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United States Census 2020. UPC 8 19845 00598 5
Where it was distributed
Nationwide USA and Canada
Questions about this recall
Why was it recalled?
CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Which lots are affected?
Lot: MFG: 2020/05/10 L/N: 20200510-3
Where was it sold?
Nationwide USA and Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 87037This product is part of a recall event; the main page for the event is IMC Wash-Free Hand Sanitizer, (ethyl alcohol) recalled by Shane Erickson.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IMC Wash-Free Hand Sanitizer, (ethyl alcohol) recalled by Shane Erickson | Shane Erickson | Potency & Assay | Nationwide | |
| CLASS II | IMC Wash-Free Hand Sanitizer, (ethyl alcohol) recalled by Shane Erickson | Shane Erickson | Potency & Assay | Nationwide |
More recalls from Shane Erickson
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | IMC Wash-Free Hand Sanitizer, (ethyl alcohol) recalled by Shane Erickson | Shane Erickson | Potency & Assay | Nationwide |
| Drug | CLASS II | IMC Wash-Free Hand Sanitizer, (ethyl alcohol) recalled by Shane Erickson | Shane Erickson | Potency & Assay | Nationwide |