FDAClass IIJune 22, 2022

Alcohol Antiseptic 80% recall: CGMP Deviations

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.

Why was Alcohol Antiseptic 80% recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 54931, No Expiration date.

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.
Recalling firm
A.P. Nonweiler
Quantity
833 gallons
Distribution
Distributed in States of WI and VA
Recall date
June 22, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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