Array Liquid Antiseptic Handwash Recalled for Microbiological Test Failures
Midlab Incorporated is recalling Array Liquid Antiseptic Handwash due to manufacturing quality deviations. The product failed microbiological testing and may not provide adequate antimicrobial protection.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—microbiological contamination resulting in inadequate antimicrobial efficacy—represents a risk-of-harm product where no injury has been reported, meeting the High (3) criteria.
Plain-English summary
Midlab Incorporated is recalling Array Liquid Antiseptic Handwash, Lot 0711241, 128 fl oz (1 gallon), Chloroxylenol 0.1%, distributed nationwide by Gordon Food Service in Wyoming, MI.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations related to out-of-specification microbiological test results. The product failed to meet manufacturing quality standards and may not provide the antimicrobial protection for which it is intended.
Consumers and businesses in possession of this product should discontinue use and dispose of it appropriately. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
- Manufacturer
- Midlab Incorporated
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 (1)
- Lot 0711241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Midlab Incorporated 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 6 products in this recall →Related recalls
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