Home / Recalls / A.P. Nonweiler / D-1142-2022

D-1142-2022 Class II Ongoing

Recalled by A.P. Nonweiler — Oshkosh, WI

Recall Details

Product Type: Drugs
Report Date: June 22, 2022
Initiation Date: May 11, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 833 gallons

Product Description

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 Pattern

Distributed in States of WI and VA

Code Information

Lot: 54931, No Expiration date.