Alcohol Antiseptic 80% recalled over sterility concerns

Recall date

May 11, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

A.P. Nonweiler recalls Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per to…

Recall number

D-1142-2022

FDA classification

Class II

Brand / firm

A.P. Nonweiler

Sold / distributed

Distributed in States of WI and VA

Why it was recalled

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tote, Product Code 9999D361-250: (b) 1 U.S. gallon, Product Code 9999D361-001: A.P. Nonweiler Co., Inc., 3321 County Road A, Oshkosh, WI 54901.