Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, Packaged as (a) 250 U.S. gallons per tot
Summary
The FDA issued a Class II for Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solution, by A.P. Nonweiler. Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits..
Details
Source
Drug Recall
External ID
D-1142-2022
Action Date
2022-06-22
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot: 54931, No Expiration date.
Quantity Affected: 833 gallons
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-11
Company
Oshkosh, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (A.P. Nonweiler) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does A.P. Nonweiler have FDA actions?
This is the only FDA action we have on record for A.P. Nonweiler in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1142-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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