Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC
Summary
The FDA issued a Class II for Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, package by Adam's Polishes LLC. Reason: CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to .
Details
Source
Drug Recall
External ID
D-0067-2023
Action Date
2022-11-23
Status
Ongoing
Category
drug
Product Description
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz. (3,785 ml.) jug, NDC 74943-125-28, Manufactured by B&B Blending, LLC, Northglenn, CO.
Lot/Code Info: Lots: 133470, 133471, 133472, 133473, 133474, 133476, 133477, 133478, 133479, 133480, 133481, 133482, 133483, 137731, 137732, 137733, 137734, 139322, 143327
Quantity Affected: 3,441 gallons total
Reason for Recall
CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-05
Company
Thornton, CO
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 23 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Adam's Polishes LLC has 2 FDA actions in our database, including 2 recalls.
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 (Adam's Polishes LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Adam's Polishes LLC have FDA actions?
Adam's Polishes LLC has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0067-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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