Elevated risk U.S. Food and Drug Administration

Family Dollar Various OTC medical products recall: Product was stored outside of labeled temperature requirements

Recall published 4+ years ago

Product was stored outside of labeled temperature requirements.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Product was stored outside of labeled temperature requirements.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
August 5, 2022
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Family Dollar
Product type
Medical devices
Sold at
Family Dollar

Products covered by this recall

Various OTC medical products

What the company announced

Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled temperature requirements. This notice covers the recall of Over-the-Counter Medical Devices. An earlier notice issued July 21, 2022 covered a related recall of Over-the-Counter Pharmaceutical Products.

To date, Family Dollar has not received any consumer complaints or reports of illness related to this recall. This recall is being conducted out of an abundance of caution.

A list of the recalled products is attached. This recall goes to the retail store level. Not all of the products listed were sent to all stores.

Family Dollar has notified its affected stores asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product. Customers that may have bought affected product may return such product to the Family Dollar store where they were purchased without receipt. This recall does not apply to Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, Washington, Alaska, or Hawaii as Family Dollar does not have any stores in Alaska or Hawaii and no Family Dollar stores in any of the other states received any products subject to this recall.

Customers with questions regarding this recall may contact Family Dollar Customer Service at 844-636-7687 between 9am and 5pm EST. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

https://www.fda.gov/safety/report - problem - fda

Recalled Products

  • 900260: 900794 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 900794 LS SKYN NON LATEX LUBRICATED CONDOM 3CT
  • 900260: 901260 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 901260 VERIQUICK PREGNANCY TEST 1CT
  • 900260: 902343 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 902343 FIRST RESPONSE 2 CT
  • 900260: 903409 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 903409 SKYN ORIGINAL NON LATEX CONDOM 12CT
  • 900260: 903415 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 903415 SKYN ELITE NON LATEX CONDOM 12CT
  • 900260: 939504 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 939504 VERIQUICK PREGNANCY TEST 1 CT
  • 900260: 900752 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 900752 AT HOME MARIJUANA TEST STRIP
  • 900260: 902816 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 902816 TROJAN ULTRA RIBBED LUBED 3CT
  • 900260: 903756 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 903756 VERIQUICK PREGNANCY TEST 2 CT
  • 900260: 999763 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 999763 TROJAN ULTRA THIN CONDOM LATEX 3CT
  • 900260: 998221 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 998221 SKYN ELITE LARGE NON LATEX CONDOM 12CT
  • 900260: 998869 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 998869 PREFERRED UTI TEST 1 CT
  • 900260: 900265 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 900265 LIFESTYLES ULTRA SENSITIVE CONDOMS 12CT
  • 900260: 900531 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 900531 CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO
  • 900260: 999009 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 999009 B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ
  • 900260: 902274 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 902274 GS SALINE SOLUTION 12FL OZ
  • 900260: 901443 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 901443 KY JELLY LUBRICANT 2 FL OZ
  • 900260: 901960 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 901960 OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
  • 900260: 999801 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 999801 SIMPLY SALINE NASAL MIST 3.1 OZ
  • 900260: 900457 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: OPTI FREE PURE MST DSINFCTNG SLTN 4FL OZ
  • 900260: 902139 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 902139 DENTEMP ONE STEP .077OZ
  • 900260: 906018 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 906018 FIXODENT ORG CREAM 2.4OZ
  • 900260: 998762 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 998762 DRTALBOT TDDLR TTHPSTE BRSH TUTTI FRUTTI
  • 900260: 905076 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 905076 CURAD STRNG WATRPRF STRIP 1IN 20CT
  • 900260: 906312 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 906312 GS DENTURE CLEANSER GRN TAB 40CT
  • 900260: 999619 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 999619 FIXODENT ADH CREAM ULTRA MAX HOLD 2.2OZ
  • 900260: 999037 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 999037 CURAD FIRST AID KIT
  • 900260: 903377 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 903377 POLIGRIP POWER MAX HOLD 2.2OZ
  • 900260: 999417 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 999417 NEW SKIN LIQUID BANDAGE CLEAR .3FL OZ
  • 900260: 900737 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 900737 TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT
  • 900260: 901239 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 901239 FIXODENT ORG CREAM TRAVEL .75OZ
  • 900260: 906131 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 906131 POLIDENT DENTURE CLNS TAB 28CT
  • 900260: 900334 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 900334 POLIGRIP ADH CREAM FREE 2.4OZ
  • 900260: 906023 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 906023 GS DENTURE CLEAN OVRNT TAB 40CT
  • 900260: 901634 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 901634 POLIDENT DENTURE CLEANSERS 84 CT
  • 900260: 901777 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 901777 POLIDENT OVERNIGHT WHITENING TAB 28CT
  • 900260: 906402 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 906402 FIXODENT ADH CREAM WITH SCOPE 2OZ
  • 900260: 999632 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 999632 POLIGRIP EXTRACARE ADHESIVE CREAM 2.2OZ
  • 900260: 900085 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 900085 SUPER POLIGRIP ADH CREAM .75OZ
  • 900260: 900723 · 900260 CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT: 900723 POLIGRIP DENTURE ADHESIVE ORIGINAL 2.4OZ

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 17 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • 900260 900794

Package size

Match the net weight or the piece count on the front of the pack.

  • 1 CT
  • 3 CT
  • 2 CT
  • 12 CT
  • 4 FLOZ
  • 12 FL OZ
  • 2 FL OZ
  • 2 OZ
  • 3.1 OZ
  • 4 FL OZ
  • 2.4 OZ
  • 20 CT
  • 40 CT
  • 2.2 OZ
  • 28 CT
  • 84 CT

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Family Dollar — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Family Dollar — Consumers: Family Dollar Customer Service, 844-636-7687

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Family Dollar medical devices recalled?

Product was stored outside of labeled temperature requirements. Product was stored outside of labeled temperature requirements.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 900260 900794. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

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