Why it was recalled
GMP Deviations: Potential to contain 1-propanol.
Product description
Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
CA, NY and Mexico
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-1592-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 18, 2020
- FDA report date
- Sep 30, 2020
- Quantity
- a)19,440 liters b) 25,917 gallon
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nanomateriales Sa De Cv
Original FDA data
Every field from FDA enforcement report D-1592-2020, exactly as published.
Show all FDA fields
- City
- Ciudad Apodaca
- Status
- Terminated
- Country
- Mexico
- Event ID
- 86333
- Address
- Avenida Milimex 215
- Address (line 2)
- Col. Milimex, Apodaca
- Code information
- All lots
- Report date
- Sep 30, 2020
- Product type
- Drugs
- Recall number
- D-1592-2020
- Classification
- Class II
- Recalling firm
- Nanomateriales Sa De Cv
- Product quantity
- a)19,440 liters b) 25,917 gallon
- Termination date
- Jul 5, 2024
- Reason for recall
- GMP Deviations: Potential to contain 1-propanol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 531151); b) 1 gal (3.76L) (NDC 69912-008-02 UPC 2 000000 531144) bottles, Distributed by Fujimura Trading S.A. DE C.V. Juventino Rosas 1902, Col. Caracol, 64810, Monterrey, N.L., Mexico Nanomateriales S.A. DE C.V.
- Distribution pattern
- CA, NY and Mexico
- Recall initiation date
- Aug 18, 2020
- Initial firm notification
- Telephone
- Center classification date
- Sep 23, 2020