IMC Wash-Free Hand Sanitizer Recalled for Methanol Contamination
Shane Erickson Inc is recalling IMC Wash-Free Hand Sanitizer because it was manufactured at a facility that produced subpotent product containing methanol.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves methanol contamination, a significant hazard that can cause serious injury, and the FDA has classified it as Class II.
Plain-English summary
Shane Erickson Inc is voluntarily recalling 36,505 bottles of IMC Wash-Free Hand Sanitizer, 75% ethyl alcohol, 1.7 fl. oz. (50 ml). The product was distributed nationwide in the United States and Canada. The recall is due to Current Good Manufacturing Practice (CGMP) deviations; the product was manufactured at the same facility that produced a product FDA sampled and found to be subpotent for ethanol and to contain methanol.
The recalled product is identified by Lot 2020/05/11 and expiration date 2023/05/10. It is distributed by IMC, 4284 Shoreline Dr, Spring Park, MN 55384, and made in China. The product was also distributed with custom front labels for Sadie G. Mays Health & Rehabilitation Center, Pacers logo, Northwood Church, ROGERTHEROOFER.com, and SoFi Stadium Wash-Free Hand Sanitizer. The UPC is 8 19845 00597 8.
Consumers should stop using the product and contact the recalling firm for instructions on return or disposal. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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)…
- Manufacturer
- Shane Erickson Inc
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 36,505
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 2020/05/11
- exp 2023/05/10
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Shane Erickson Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Shane Erickson Inc
See all →- SevereIMC Wash-Free Hand Sanitizer Recalled for Methanol Contamination
FDA (Drugs) · 2021-02-03
- SevereIMC Wash-Free Hand Sanitizer Recalled for Methanol Contamination
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