Family Dollar OTC medical products - recalled due to storage outside of labeled temperature, USA

1 year ago •source www.fda.gov

Recall notice

United States

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.

- Recalled products:

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

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 should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

Company name: Family Dollar
Brand name: Multiple brand names
Product recalled: Various OTC medical products
Reason of the recall: Product was stored outside of labeled temperature requirements.
FDA Recall date: September 16, 2022

Source: www.fda.gov

#medicaldevices #familydollar #us #cream #sub #ham #ro-tel #jell-o

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Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating … See More
inside of the vial.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Eugia US LLC has not received any reports of adverse events related to this recall.

Methocarbamol injection USP 1000 mg/10 mL (100mg/mL), is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is packaged in 10 mL and packed as 25 (vials) X 04 (Printed E-Flute cartons) X 01 (Shipper) with NDC code as 55150-223-10. Eugia US LLC shipped the entire lot to wholesalers nationwide from Jan 12, 2024, through Jan 16, 2024.

The product can be identified by product name on carton and vial label and with lot number 3MC23011 and Exp. Date: Nov 2026 (NDC 55150-223-10) (See enclosed vial label). The product label is as shown in the image below.

Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hospitals, pharmacies, institutions, and doctors with an existing inventory of the recalled product lot should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product lot, notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.

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Company name: Eugia US LLC
Brand name: Eugia US LLC
Product recalled: Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)
Reason of the recall: Device & Drug Safety – Presence of Particulate Matter
FDA Recall date: March 28, 2024

Source: www.fda.gov
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