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Isopropyl alcohol FDA Alerts

The FDA Alerts below may be specifically about isopropyl alcohol or relate to a group or class of drugs which include isopropyl alcohol.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for isopropyl alcohol

Tennessee Technical Coatings Corp. Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Due to Presence of Methanol

March 07, 2022 -- Tennessee Technical Coatings Corp. is voluntarily recalling all lots of HAND SANITIZER Isopropyl Alcohol Antiseptic 75% to the consumer/user level. FDA analysis has found the product to contain methanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache blurred vision, coma, seizures, permanent blindness, permanent damage to the central nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, Tennessee Technical Coatings Corp. has not received any reports of adverse events related to this recall.

These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. HAND SANITIZER Isopropyl Alcohol Antiseptic 75% is packaged in one-gallon plastic jugs. The affected HAND SANITIZER Isopropyl Alcohol Antiseptic 75% lots include the following batch numbers:

Batch Number Container Size NDC
00421002 One Gallon 76921-000-01
00422001 One Gallon 76921-000-01
00429001 One Gallon 76921-000-01
00521001 One Gallon 76921-000-01
00622003 One Gallon 76921-000-01
00806001 One Gallon 76921-000-01

The product can be identified by the representative label below. The hand sanitizer was distributed in Tennessee, USA to retail customers and to wholesale companies who further distributed between approximately April 2020 and August 2020.

Tennessee Technical Coatings is notifying its distributors and customers by letter, and telephone and is arranging for return of all recalled products. Consumers/distributors/retailers that have HAND SANITIZER Isopropyl Alcohol Antiseptic 75% which is being recalled should stop using, return to place of purchase/contact their doctor.

Consumers with questions regarding this recall can contact Tennessee Technical Coatings by calling 931-359-6666 or via the e-mail address ttchelpdesk@tntechcoatings.net Monday through Thursday 8am-5pm central standard time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA


Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

[Posted 12/05/2017]

ISSUE: Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. The affected lots are:

SD2070421201 (Exp. 12/2019)
SD2070420925 (Exp. 09/2019)
SD2070420601 (Exp. 12/2019)

The affected lots were distributed between 10/18/2016 and 07/19/2017.

The use of impacted Alcohol Prep Pads could result in adverse events such as infections.

BACKGROUND: Pharmacist Choice Alcohol Preps are supplied to distributors and pharmacies. Pharmacist Choice Alcohol Preps are used by health care professionals and patients for preparation of the skin prior to injection, as well as in first aid to decrease germs in minor cuts, scrapes and burns.

RECOMMENDATION: Simple Diagnostics is notifying its distributors and customers by issuing a “Dear Customer” letter and arranging for the return of all recalled products. Healthcare providers that have affected lots of Pharmacist Choice Alcohol Prep Pads that have been recalled should stop using the product and should return them to Simple Diagnostics.

Health professionals and consumers with questions regarding this recall can contact Simple Diagnostics at 1-877-342-2385.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[11/30/2017 - Press Release - Simple Diagnostics]


Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection

ISSUE: The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes to enhance the safe use of certain over-the-counter (OTC) topical antiseptic products. This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation.  When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections.  However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users.  Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection.
Outbreaks associated with the use of contaminated topical antiseptics have been reported in the medical literature and to the Centers for Disease Control and Prevention (CDC). Clinical infections have also been reported to FDA, leading to some product recalls.  The reported outcomes ranged from localized infections at injection sites to systemic infections that resulted in death.  FDA has reviewed reports of four deaths, five cases of wound infection, seven cases of peritonitis, 10 cases of septic arthritis, 14 cases of indwelling catheters requiring replacement, 16 cases of injection site infection, and 32 cases of bacteremia.  These infections have been confirmed to be caused by contaminated antiseptic products.  Affected products included all commonly used antiseptic ingredients, including alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products.  Organisms implicated in the outbreaks included Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus.

BACKGROUND: Over-the-counter (OTC) topical antiseptic drugs for use according to the label instructions to reduce the number of bacteria on the skin prior to surgery or injections. When used properly, over-the-counter (OTC) topical antiseptics are safe and effective products to reduce the number of bacteria on the skin prior to surgery or an injection.  Commonly used products contain isopropyl or ethyl alcohol, povidone iodine, poloxamer iodine, benzalkonium chloride, benzethonium chloride, or chlorhexidine gluconate as a single agent or in combination with alcohol. These products are marketed as solutions, swabs, pads saturated with a solution, and applicators containing a solution. Currently available as both single-use and multiple-use products. 

Topical antiseptics are not required to be manufactured as sterile and so may become contaminated with bacteria during manufacturing. Labeling stating a product is sterile means it was treated with a process during manufacturing to eliminate all potential microorganisms. However, even topical antiseptics manufactured with a sterile process, can become contaminated if proper care is not taken when using them.  The term nonsterile on the product label means it was not sterilized during manufacturing; it does not mean the product contains harmful bacteria.

RECOMMENDATION: To further reduce the risk of infection with improper topical antiseptic use and the possibility of these products becoming contaminated with bacteria during use, we are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers.

  • To reduce the risk of infection, ensure the products are used according to the directions on the label.
  • The antiseptics in these single-use containers should be applied only one time to one patient. 
  • We also recommend that health care professionals and patients do not dilute antiseptic products after opening them. 
  • Applicators and any unused solution should be discarded after the single application.


[11/13/2013 - Drug Safety Communication - FDA] 
[11/13/2013 - Questions and Answers - FDA]


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