RecallHawk
Class I Recall

SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black an

Scentsational Soaps & Candles Inc

Summary

The FDA issued a Class I for SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Sol by Scentsational Soaps & Candles Inc. Reason: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde..

Details

Source

Drug Recall

External ID

D-0670-2021

Action Date

2021-07-28

Status

Terminated

Category

drug

Product Description

SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection

Lot/Code Info: Lot #: 20255

Quantity Affected: a) 4,680 bottles; b) 4,968 bottles

Reason for Recall

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Distribution

USA Nationwide

Type: Voluntary: Firm initiated

Recall Initiated: 2021-04-27

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 49 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.

Scentsational Soaps & Candles Inc has 19 FDA actions in our database, including 19 recalls.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

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 (Scentsational Soaps & Candles Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Scentsational Soaps & Candles Inc have FDA actions?

Scentsational Soaps & Candles Inc has 19 FDA actions in our database, including 19 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "D-0670-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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