FDA recall D-1142-2022

Product

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.

Reason for recall

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

Distribution

Distributed in States of WI and VA

Key facts

Status

Ongoing

Initiation date

2022-05-11

Report date

2022-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oshkosh, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1142-2022