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 people using these products on their hands are at risk, young children who accidentally 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.
Original recall and updates at FDA