HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings
Summary
The FDA issued a Class I for HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.7 by Tennessee Technical Coatings, Corp.. Reason: Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol..
Details
Source
Drug Recall
External ID
D-0739-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
Product Description
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
Lot/Code Info: Batch #:00806001, No EXP date on label.
Quantity Affected: 169.2 gallons
Reason for Recall
Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
Distribution
Distributed in AL, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-03
Company
Lewisburg, TN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Tennessee Technical Coatings, Corp. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Tennessee Technical Coatings, Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tennessee Technical Coatings, Corp. have FDA actions?
Tennessee Technical Coatings, Corp. 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-0739-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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