Zanilast+ Gel Antiseptic Hand Sanitizer

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

GMP Deviations: Potential to contain 1-propanol.

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

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.

Affected NDCs 69912-0008-01 69912-0008-02

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol

Recalling firm: Nanomateriales Sa De Cv
NDC code: 69912-008-01
Origin: N/A, Mexico
Initiated by: Voluntary: Firm initiated
FDA recall number: D-1592-2020 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.