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Philips Respironics CPAP or Bi-Level PAP therapy masks - recalled due to potential risk of serious injury, USA
1 month ago
These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.
Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body. The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry.
This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing such magnetic clips to inform them of the updated instructions and labeling. All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described below. This represents a new and industry-leading practice.
Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to:
- Implantable cardioverter defibrillators (ICD)
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
- Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (e.g., glaucoma implants, retinal implants)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (e.g., insulin pumps)
- Hypoglossal nerve stimulators
- Devices labeled as MR (Magnetic Resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
Patients should stop using the affected mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a non-magnetic mask if available, for continued therapy.
Patients should properly dispose of the mask that has magnets after an alternative is obtained. These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.
Warning: Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 15 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers, and bed partners that may be in close vicinity to patients that use the masks.
Impacted masks include: More than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date. As of August 30, 2022, Philips Respironics has received 14 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator (AICD), seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues.
Patients may contact their Durable Medical Equipment (DME) provider, which supplied the masks affected by this notice. This voluntary medical device corrective action has been reported to the regulatory agencies in the countries where these masks are available.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Royal Philips’ subsidiary Philips Respironics
Brand name: Philips
Product recalled: Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps
Reason of the recall: potential risk of serious injury
Spot and Tango announced the recall of 4 batches of their Chicken and Brown Rice UnKibble Dog Food because samples tested positive for Salmonella bacteria.
The recalled product is Chicken and Brown Rice UnKibble Dog Food, with the codes:
-Lot Code T-22220 and SKU Number U-C-004
-... Lot Code T-22223 and SKU Number U-C-005
- Lot Code T-22220 and SKU Number U-C-006
- Lot Code T-22228 and SKU Number U-C-003
No other Spot & Tango products are affected by this recall.
Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Dogs with Salmonella infections will most likely not exhibit any symptoms, though in rare cases they may be lethargic and have diarrhea (which may be bloody), fever, and vomiting. Some dogs may have only decreased appetite, fever, and abdominal pain. Infected but otherwise healthy dogs can be carriers and infect other animals or humans through the fecal-oral route.
If you have the recalled product in your home, please stop feeding it to your dogs and dispose of it immediately.
2 weeks ago
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
Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill lot 20210912 and lot 31853-501, expiry 09/24, packaged in 10-count blisters co-packaged in a carton and in 60-count bottles to the consumer level. Proper Trade LLC/My Stellar Lifestyle was notified by Amazon that laboratory analysis has found... the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in Wonder Pill capsules makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.
Consumers with underlying medical issues who take the Wonder Pill with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Proper Trade LLC/ My Stellar Lifestyle has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters co-packaged in a carton, ASIN B0B6CWC9NK, and packaged in a 60-count bottle. The affected lots include lot numbers’ 20210912 & 31853-501, Expiry 09/24. The product can be identified by the labels below. The product was distributed via the internet and fulfilled by Amazon at www.amazon.com and Walmart at www.walmart.com, nationwide in the USA.
On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
Proper Trade LLC/ My Stellar Lifestyle is notifying its customers by this press announcement and sending Amazon & Walmart messages to its customers and is arranging for return of all recalled products. Consumers that have Wonder Pill capsules which is being recalled should stop using the product.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company name: Proper Trade LLC/My Stellar Lifestyle
Brand name: My Stellar Lifestyle
Product recalled: Wonder Pill Capsules
Reason of the recall: Product contains undeclared tadalafil
FDA Recall date: September 28, 2022
Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary... recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of abundance of caution.
Product Description: Clopidogrel 75mg Tablets, 1,000 Count Bottle, GSMS NDC: 51407-032-10, Lot #: GS046745, Expiration Date: 12/2023
Product Description: Atenolol 25mg Tablets, 1,000 Count Bottle, GSMS NDC: 60429-027-10, Lot #: GS046745, Expiration Date: 12/2023
Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems as indicated in the product labeling. For more drug label information about clopidogrel bisulfate visit: DailyMed - CLOPIDOGREL- clopidogrel bisulfate tablet, film coated (nih.gov). For more drug label information about atenolol visit: DailyMed - ATENOLOL tablet (nih.gov)
Patients who suddenly stop taking atenolol, as would happen if clopidogrel were misplaced in the atenolol-labeled bottle, are at increased risk for ischemic (angina, myocardial infarction), hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta antagonism. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen. To date, GSMS, Inc. has not received any reports of adverse events related to the use of the products as part of this recall.
The lot under GSMS, Inc.’s voluntary recall has been primarily sold to AmerisourceBergen, and McKesson. AmerisourceBergen and McKesson are instructed to immediately stop distribution, quarantine all remaining products in their control, and return the recalled product to GSMS, Inc. They are also instructed to provide their customers, i.e., pharmacies and consumers, a copy of GSMS, Inc.’s recall notification, recall response form, and letter to consumers, patients, and caregivers.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Golden State Medical Supply, Incorporated
Brand name: Golden State Medical Supply, Incorporated
Product recalled: Clopidogrel 75mg Tablets, Atenolol 25mg Tablets
Reason of the recall: Due to Label Mix-up
FDA Recall date: September 29, 2022
The boil water advisory that was in effect in the City of Reidsville has been lifted as of 11:04 a.m. on Friday.
Beckley Water Company has issued a boil water advisory for the Midway Road, Monson Court, Pemberton Road, Carter Avenue, Blue Room Road, Hatfield Road, Valley View Road, Ballard Street, 1st Avenue, Roselawn Avenue, Brammer Avenue, and Broadway Avenue areas.
Lake View city officials announced this (Friday) morning that the boil order issued earlier this week for customers on the community’s water supply has been lifted.
1 hour ago
A power outage affecting more than 2,000 customers was reported in downtown Cape Girardeau shortly after 10 a.m. on Friday, October 7. the outage was caused by an equipment issue when a switch on the system failed.
Outage link: outagemap.ameren.com
Electric power was knocked out to parts of Logan early this morning (Friday, Oct. 7) when a large dump truck whose driver had neglected to lower the vehicle’s dump bed tore down traffic lights and utility lines above state Route 93/Mulberry Street at the intersection with Front... Street. Power was out to many nearby businesses as of around 9:30 a.m. Friday.
Outage link: outagemap.aepohio.com.s3.amazonaws.com