Why it was recalled
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.
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 numbers, UPCs & expiration codes
Batch #: 00421002, 00422001, 00429001, 00521001, 00622003, No EXP date on label.
Where it was sold
Distributed in AL, TN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0740-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 3, 2022
- FDA report date
- Mar 30, 2022
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tennessee Technical Coatings, Corp.
Original FDA data
Every field from FDA enforcement report D-0740-2022, exactly as published.
Show all FDA fields
- City
- Lewisburg
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 89705
- Address
- 1421 Higgs Rd
- Code information
- Batch #: 00421002, 00422001, 00429001, 00521001, 00622003, No EXP date on label.
- Postal code
- 37091-4401
- Report date
- Mar 30, 2022
- Product type
- Drugs
- Recall number
- D-0740-2022
- Classification
- Class II
- Recalling firm
- Tennessee Technical Coatings, Corp.
- Termination date
- Dec 2, 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed in AL, TN
- Recall initiation date
- Mar 3, 2022
- Initial firm notification
- Press Release
- Center classification date
- Apr 4, 2022