Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash G
Summary
The FDA issued a Class II for Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthw by Family Dollar Stores, Llc.. Reason: CGMP Deviations: product held outside appropriate storage temperature conditions..
Details
Source
Drug Recall
External ID
D-1368-2022
Action Date
2022-08-31
Status
Ongoing
Category
drug
Product Description
Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint 1 LTR SKU 908114 Colgate Peroxyl Antiseptic Mouth Sore Rinse 8.4 FL OZ SKU 998273 Listerine Cool Mint Mouthwash 50.72 FL OZ SKU 999050 Swan Spring Mint Antiseptic Mouth Rinse 8.5 OZ SKU 900273 Swan Original Antiseptic Mouth Rinse 8.5 OZ SKU 900938 Colgate Optic White Mouthwash 16 FL OZ SKU 999043 Crest Scope Classic Original Min Mouthwash 1 Ltr SKU 908109 Listerine Cool Mint Mouthwash 500 mL SKU 908223 Act Kids Bubble Gum Blowout Mouthwash 16.9 Fl OZ SKU 999935 Swan Ice Mint Antiseptic Mouth Rinse 8.5 OZ SKU 903150 Swan Mouthwash Cool Mint 1 Liter SKU 908466 Crest Mouthwash Pro Health Multi Protection Mint 1 Liter SKU 908123, Colgate Mouthwash Total Advanced Peppermint Blast 1 Liter SKU 903156 Listerine Total Care Freshmine 1 Liter SKU 900980 Listerine Ultra Clean Cool Mint 1 Liter SKU 901904 Listerine Mouthwash Freshburst 1 Liter SKU 903159 Listerine Mouthwas Original Amber 1 Liter SKU 908004 Listerine Mouthwash Coolmint 1 Liter SKU 908005 Swan Antiseptic Rinse Amber 1 Liter SKU 908465 Crest Scope Mouthwash All Day 1 Liter SKU 998269 Listerine Mouthwash Coolmint 95 Milliliters SKU 999752 Swan Fresh Mint Mouthwash 1 Liter SKU 999762 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Lot/Code Info: SKUs: 900733; 902704; 908114; 998273; 999050; 900273; 900938; 999043; 908109; 908223; 999935; 903150; 908466; 908123; 903156; 900980; 901904; 903159; 908004; 908005; 908465; 998269; 999752; 999762
Quantity Affected: Unknown.
Reason for Recall
CGMP Deviations: product held outside appropriate storage temperature conditions.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-23
Company
Chesapeake, VA
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 272 drug-related FDA actions this month.
Family Dollar Stores, Llc. has 149 FDA actions in our database, including 149 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 (Family Dollar Stores, Llc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Family Dollar Stores, Llc. have FDA actions?
Family Dollar Stores, Llc. has 149 FDA actions in our database, including 149 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1368-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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