Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfi
Summary
The FDA issued a Class II for Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic by AMS Packaging Inc. Reason: Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol..
Details
Source
Drug Recall
External ID
D-1148-2022
Action Date
2022-06-22
Status
Ongoing
Category
drug
Product Description
Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), 8 oz/ 236 ML plastic bottles; Premium Nature, South Plainfield, NJ. UPC 819192028668
Lot/Code Info: all lots
Quantity Affected: unknown
Reason for Recall
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-10
Company
South Plainfield, NJ
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.
AMS Packaging Inc has 3 FDA actions in our database, including 3 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 (AMS Packaging Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AMS Packaging Inc have FDA actions?
AMS Packaging Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1148-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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