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COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SEN...

FDA Drug Recall #D-1367-2022 — Class II — June 23, 2022

Recall Summary

Recall Number D-1367-2022
Classification Class II — Moderate risk
Date Initiated June 23, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Family Dollar Stores, Llc.
Location Chesapeake, VA
Product Type Drugs
Quantity Unknown

Product Description

COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SENSODYNE REPAIR AND PROTCT WHITNG 3.4 OZ SKU 901003 COLGATE BSPW PASTE BRISK MINT 6 OZ 2PK SKU 901658 COLGATE MAX FRESH COOL MINT 6OZ 2PK SKU 901785 COLGATE BSPW PASTE 6 OZ 3PK SKU 902143 CREST CMPLT SCOPE OUTLST PSTE 5.4OZ 2 PK SKU 902701 COLGATE TOTAL WHITENING TP 4.8 OZ SKU 902967 CREST 3D WHITE BRILLIANCE CHARCOAL 3.9 OZ SKU 903463 COLGATE BSPW GEL FROSTY MINT 6 OZ SKU 905026 ARM & HAMMER COMPLETE CARE BKS PRX TP 6 OZ SKU 905028 COLGATE BSPW PASTE BRISK MINT 2.5 OZ SKU 905703 COLGATE BSPW PASTE BRISK MINT 6 OZ SKU 907121 CREST BS N PX WHTE TUBE FRESH MINT 5.7 OZ SKU 907125 COLGATE SPARKLING WHITE MINT ZING 2.5 OZ SKU 907151 ARM & HAMMERADV WHITE TP 4.3 FL OZ SKU 907766 COLGATE MAX FRESH COOL MINT TP 6 OZ SKU 907839 CREST COMPLETE SCOPE OUTLAST TP 5.4 OZ SKU 907872 COLG MAX FRESH COOL MINT TP 6.3 OZ 3PK SKU 998200 COLGATE OW STAIN FIGHTR TOOTHPASTE 4.2 OZ SKU 998278 COLGATE MAX FRESH WHTNING CHRCOAL TP 6 OZ SKU 998881 COLGATE CHARCOAL TP 2.2 OZ SKU 998902 CREST 3D WHITE STAIN ERASER 3.1OZ TWN PK SKU 999286 COLGATE ESSENTIALS CHARCOAL PASTE 4.6 OZ SKU 999318 COLGATE TOTAL CLEANMINT TOOTHPASTE 4.8 OZ SKU 999498 COLGATE OW STAINFIGHTERCLEANMNT4.2OZ 2PK SKU 999633 COLGATE OW STAIN FIGHTER CLEAN MNT 4.2 OZ SKU 999750 COLGATE DEEP CLEAN GEL TOOTHPASTE 2.5 OZ SKU 999916 CREST TARTAR PROTECTION PASTE 5.7 OZ SKU 900353 COLGATE TOTAL WHITENING GEL 4.8OZ 2 PK SKU 903152 CREST CAVITY PROTECTION PASTE 5.7 OZ SKU 907327 CREST PRO HEALTH WHITENING GEL TP 4.6 OZ SKU 999760 AIM CAVITY PRTCT MINT GEL 4.5 OZ SKU 999910 CREST 3D WHITE RADIANT MINT 2.7 OZ SKU 907160 CR FRESH WHT PEP GIM 2.4 OZ SKU 900791 COLGATE SENSITIVE WHITENING PASTE 6 OZ SKU 901677 COLGATE TRIPLE ACTION 2.5 OZ SKU 907170 COLGATE OW STAIN PREVENTION TP 2.1 OZ SKU 998277 CREST 3D WHITE CHARCOAL 2.7 OZ SKU 999282 ARM & HAMMER PEROXICARE MINT PASTE 6 OZ SKU 999937 CREST ANTI CAVITY PASTE 2.4 OZ SKU 907165 CLOSE UP CINN RED GEL TP 4 OZ SKU 907220 COLGATE BSPW GEL TP 6OZ 3PK; SKU 902966 COLGATE TOTAL WHTN GEL TP 4.8 OZ SKU 906406 COLGATE CAVITY PROTECTION 6 OZ SKU 907329 COLGATE MAX FRSH ADV WHTN CLN MNT TP 6 OZ SKU 998257 CG OW SF MINT PASTE 2.0 OZ SKU 999723 COLGATE KIDS JUNIOR BUBBLE FRUIT 3.5 OZ SKU 900592 CREST BKING SDA PEROXIDE WHTNG TP 2.4 OZ SKU 907865 CREST KIDS SPRKL TPST 2.2 OZ SKU 901243 CREST 3D WHITE ARTIC FRESH 2.7 OZ SKU 905045 COLGATE RENEWAL GUM REVITALIZE TP 3 OZ SKU 998741 ULTRA BRITE ADV WHITENING TP 6 OZ SKU 902134 COLGATE BASE DEEP CLEAN GEL 6 OZ SKU 900728 COLGATE TOTAL WHTN PASTE TP 4.8OZ 2PK SKU 901784 SENSODYNE PRO NAMELGENTLE WHT 2.7 OZ SKU 902124 SWAN ULTRA CLEAN ARCTIC MINT 33.8 FL OZ SKU 902840 CREST 3DW ULTRA WHITE 3 OZ SKU 903453 COLGATE KIDS TP ASRTD CHARACTERS 4.6 OZ SKU 905517 PEPSODENT ORIGINAL TP 4.5 OZ SKU 907136 SENSODYNE EXTRA WHTEN TP 2.7 OZ SKU 907781 CREST PSTE DNSIFY DAILY WHITENING 4.1 OZ SKU 998268 ORAJEL PP FLUORIDE TOOTHPASTE 4.2 OZ SKU 998397 CREST 3D WHITE BRILLIANCE THPASTE 2.7 OZ SKU 998730 TOM'S KIDS STRAWBERRY ANTICAVITY 5.1 OZ SKU 999099 CREST 3D WHITE STNERSR ICY CLN MNT 3.1 OZ SKU 999285 SENSODYNE COMPLETE FRESH PASTE 3.4 OZ SKU 902363 CREST PRO HEALTH DEEP CLEAN TP 3.5 OZ SKU 903245 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Reason for Recall

CGMP Deviations: product held outside appropriate storage temperature conditions.

Distribution Pattern

Nationwide within the United States

Lot / Code Information

SKUs: 900596, 900734, 901003, 901658, 901785, 902143, 902701, 902967, 903463, 905026, 905028, 905703, 907121, 907125, 907151, 907766, 907839, 907872, 998200, 998278, 998881, 998902, 999286, 999318, 999498, 999633, 999750, 999916, 900353, 903152, 907327, 999760, 999910, 907160, 900791, 901677, 907170, 998277, 999282, 999937, 907165, 907220, 902966, 906406, 907329, 998257, 999723, 900592, 907865, 901243, 905045, 998741, 902134, 900728, 901784, 902124, 902840, 905517, 907136, 907781, 998268, 998397, 998730, 999099, 999285, 902363, 903245, 903453

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Frequently Asked Questions

cGMP stands for Current Good Manufacturing Practice — the FDA's regulations governing drug manufacturing quality. A cGMP recall means the company failed to follow required manufacturing standards. This could involve inadequate testing, poor environmental controls, documentation failures, or process deviations. cGMP recalls do not always mean the product is directly harmful — in many cases, quality records are insufficient to confirm the product meets specifications. However, the FDA requires a recall because without proper documentation, product quality cannot be assured. These are often Class II or Class III recalls.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

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