Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ
Summary
The FDA issued a Class II for Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), by Urban Electric Power. Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits..
Details
Source
Drug Recall
External ID
D-0263-2023
Action Date
2023-02-15
Status
Terminated
Category
drug
Product Description
Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles
Lot/Code Info: All lots within expiry
Quantity Affected: a) 239 bottles, b) 6,352 bottles, c)14,963 bottles, d) 8,117 bottles, e)22 bottles, f)856 bottles, g) 707 bottles
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-01-17
Company
Pearl River, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Urban Electric Power has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Urban Electric Power) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Urban Electric Power have FDA actions?
Urban Electric Power has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0263-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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