FDA Recall D-1142-2022

A.P. Nonweiler · Oshkosh, WI

Class II Ongoing 1464 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: Lot: 54931, No Expiration date.

Quantity: 833 gallons

Reason for recall

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

Recall record

Recall number: D-1142-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed in States of WI and VA
Recall initiated: 2022-05-11
Classified by FDA Center: 2022-06-10
FDA published: 2022-06-22
Recalling firm: A.P. Nonweiler
Firm location: Oshkosh, WI

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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