EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603
Summary
The FDA issued a Class II for EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) by EnviroServe Chemicals Inc.. Reason: CGMP deviations.
Details
Source
Drug Recall
External ID
D-0667-2024
Action Date
2024-10-02
Status
Ongoing
Category
drug
Product Description
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
Lot/Code Info: Lot #: 042224-L1, Exp. Date 04/22/2025
Quantity Affected: 120 bottles
Reason for Recall
CGMP deviations
Distribution
Product was sent to one distributor in North Carolina.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-18
Company
Dunn, NC
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 31 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (EnviroServe Chemicals Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does EnviroServe Chemicals Inc. have FDA actions?
This is the only FDA action we have on record for EnviroServe Chemicals Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0667-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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