FDA Recall D-1368-2022

Family Dollar Stores, Llc. · Chesapeake, VA

Class II Ongoing 1421 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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: 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: Unknown.

Reason for recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Recall record

Recall number: D-1368-2022
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Other
Distribution: Nationwide within the United States
Recall initiated: 2022-06-23
Classified by FDA Center: 2022-08-22
FDA published: 2022-08-31
Recalling firm: Family Dollar Stores, Llc.
Firm location: Chesapeake, VA

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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