Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottl
Summary
The FDA issued a Class II for Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1 by Midlab Incorporated. Reason: CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride..
Details
Source
Drug Recall
External ID
D-1464-2022
Action Date
2022-08-31
Status
Terminated
Category
drug
Product Description
Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Products & Services, Inc. 2515 Jake Drive Ste B, Cumming, GA 30028
Lot/Code Info: Lot #: 06172022-1
Reason for Recall
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Distribution
Naionwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-08
Company
Athens, TN
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 131 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Midlab Incorporated has 8 FDA actions in our database, including 8 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 (Midlab Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Midlab Incorporated have FDA actions?
Midlab Incorporated has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1464-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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