BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Hand Rub Non-Sterile Solution, Packaged in a)
Summary
The FDA issued a Class II for BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Hand by Beak & Skiff Cider Mill, Inc.. Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits..
Details
Source
Drug Recall
External ID
N/A
Action Date
2022-04-20
Status
Terminated
Category
drug
Product Description
BEAK & SKIFF SANITIZER Alcohol Antiseptic 80%, Topical Solution Antiseptic Hand Rub Non-Sterile Solution, Packaged in a) 12OZ/355ML bottles, UPC 48558 94603 6 b) 5 Gallon/18,927ML pail C)1 Gallon/3,785ML jug; d)4OZ/118ML spray top bottles; Produced By; Beak & Skiff Farms Apple Farms Inc. Lafayette, NY 13084.
Lot/Code Info: Lot # 06090
Quantity Affected: 396/12 oz. bottles, 11/5 gallon pails, 9/1 gallon jugs, 304/4 oz. bottles
Reason for Recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits.
Distribution
Distributed in NY and sales were made via the internet.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-04
Company
La Fayette, NY
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 38 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 (Beak & Skiff Cider Mill, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beak & Skiff Cider Mill, Inc. have FDA actions?
This is the only FDA action we have on record for Beak & Skiff Cider Mill, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "N/A" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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