The Recall Desk
SevereFDA (Drugs)·D-0740-2022·Announced 2022-03-30

Hand Sanitizer Isopropyl Alcohol Recall Due to Methanol Contamination

Tennessee Technical Coatings is recalling hand sanitizer products due to CGMP deviations. Certain lots were manufactured under the same conditions as a product lot found to contain methanol.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source indicates this is an FDA Class II recall involving a CGMP deviation related to methanol contamination risk in a product meant for skin contact. Methanol toxicity through dermal absorption poses significant potential for injury, meeting the criterion for Severe severity.

Plain-English summary

Tennessee Technical Coatings Corporation is recalling Hand Sanitizer Isopropyl Alcohol Antiseptic 75% (1 U.S. Gallon/3.785 Liters, NDC 76921-000-01) distributed in Alabama and Tennessee.

The recall was initiated because the affected lots were manufactured under the same conditions as a product lot found to contain methanol. This represents a Current Good Manufacturing Practice (CGMP) deviation.

The recalled product has batch numbers 00421002, 00422001, 00429001, 00521001, and 00622003. The product has no expiration date on the label.

Consumers who have purchased this hand sanitizer should stop using it immediately. For additional information or questions, consumers should contact Tennessee Technical Coatings Corporation.

The recalled product

Product
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
Manufacturer
Tennessee Technical Coatings, Corp.
Hazard
  • methanol-contamination
  • cgmp-deviation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Batch #: 00421002
  • 00422001
  • 00429001
  • 00521001
  • 00622003
  • No EXP date on label.

Distribution

Distributed in 2 states:

  • AL
  • TN