Multi-event March 2022 FDA Recall Drug by Tennessee Technical Coatings, Corp.

This Multi-event Class II drug recall was voluntarily initiated by Tennessee Technical Coatings, Corp. on March 3, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed in AL, TN and the recall is currently terminated.

Reported Recall Events

D-0740-2022 TERMINATED D-0739-2022 TERMINATED

Recall Number: D-0740-2022

Reason for Recall
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Initiated
03-03-2022
Reported
03-30-2022
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89705
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Tennessee Technical Coatings, Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in AL, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Recall Number: D-0739-2022

Reason for Recall
Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
Initiated
03-03-2022
Reported
03-30-2022
Quantity
169.2 gallons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89705
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Tennessee Technical Coatings, Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed in AL, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-02-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Batch# :00806001, No EXP date on label.