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Recall

Updated: February 2, 2023 6:00 PM
Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination. The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a... See More multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection. The product was distributed Nationwide in the USA over the Internet.

Risk Statement: Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.

Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product is packaged in a bottle with a safety seal and are placed in a carton box. It can be identified by the photos below.

- Ezricare NDC 79503-0101-15. UPC 3 79503 10115 7
- Delsam Pharma’s NDC 72570-121-15. UPC -72570-0121-15.

Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use.

Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.

In case you experience 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. If symptoms persist, seek medical care.

Company name: Global Pharma Healthcare
Brand name: EzriCare & Delsam Pharma
Product recalled: Artificial Tears Lubricant Eye Drops
Reason of the recall: Potential microbial contamination
FDA Recall date: February 02, 2023

Source: fda.gov
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The Office for Product Safety and Standards announced the recall of a Portable electric heater 500W UK plug timer + remote control digital display because the product presents a serious risk of electric shock as the plug face did not meet the dimensional and constructional requirements of... See More the standard. This product was sold through the online marketplace (eBay) in the United Kingdom.

The affected product is:
- Portable electric heater 500W UK plug timer + remote control digital display, Barcode: 9559976086668, eBay Item Number: 115534680702, Country of Origin:China.

Hazard
The product presents a serious risk of electric shock as the plug face did not meet the dimensional and constructional requirements of the standard. The product power level was less than stated on the packaging. The supply voltage requirements stated were not compatible with the UK power network and it is assumed the product it is not for the UK market. The product should require tools to access live/hazardous parts, but it was possible to remove the grill by hand. The product does not meet the requirements of the Electrical Equipment (Safety) Regulations 2016.

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.

Risk level: Serious
Product category: Electrical appliances and equipment
Measure type: Removal of the listing by the online marketplace, Warning consumers of the risks
Recall/alert date: 30 December 2022

Source: gov.uk
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If you did not buy from ebay what do you fo
Reply 1 day ago
Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored. Product was distributed directly from Spectrum facilities nationwide... See More in the USA and to Canada.

Risk Statement: Epinephrine is a critical medication used during life-threatening conditions which can affect any age and any person. The use of a finished dose product manufactured or compounded with this recalled product could result in less-effective product, and incomplete treatment of life-threatening conditions including, low blood pressure, heart failure, anaphylaxis, irregular heartbeat, and heart attack. Treatment with a less-effective product, essentially underdosing epinephrine, could result in death. Spectrum Laboratory Products, Inc. has not received any reports of adverse events related to this recall.

Epinephrine (L-Adrenaline) USP bulk API Powder, is used in manufacturing and compounding of finished dose epinephrine prescription products which can be used to treat a variety of medical conditions including anaphylaxis and other severe immediate hypersensitivity reactions, asthma, bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictor with local anesthetics, hypotension or shock, heart failure, bradycardia or atrioventricular block, and sudden cardiac arrest.

The Epinephrine (L-Adrenaline) USP bulk API Powder is packaged in amber glass bottles enclosed in a vacuum sealed pouch. NDC’s, Package sizes, lot numbers and expiration dates can be found in the table below. The affected Epinephrine, USP product can be identified by Spectrum catalog number EP130.

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-2
Package Size: 1 KG
Lot # 1KG0865
Exp Date: 31-Mar-2023

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-1
Package Size:100 GM
Lot # 2KL0353 / 2KF0151
Exp Date: 30-Sep-2023 / 31-Mar-2023

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-4
Package Size: 1 GM
Lot # 2KL0353 / 2KF0151
Exp Date: 30-Sep-2023 / 31-Mar-2023

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-3
Package Size: 25 GM
Lot # 2KL0353 / 2KF0151
Exp Date: 30-Sep-2023 / 31-Mar-2023

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-5
Package Size: 5 GM
Lot # 2KL0353 / 2KF0151
Exp Date: 30-Sep-2023 / 31-Mar-2023

Consumers, distributors, or retail pharmacies that have Epinephrine, USP catalog number EP130, which is being recalled, should stop use immediately and return to place of purchase.

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: Spectrum Laboratory Products Inc.
Brand name: Spectrum
Product recalled: Epinephrine bulk API
Reason of the recall: Product discoloration
FDA Recall date: January 09, 2023

Source: fda.gov
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ZLINE recalled about 28,000 ZLINE gas ranges because the oven of the gas ranges can emit dangerous levels of carbon monoxide (CO) while in use, posing a serious risk of injury or death from carbon monoxide poisoning. These products were sold at Best Buy, Lowe’s, The Home... See More Depot, The Range Hood Store stores nationwide and online at www.bestbuy.com, www.build.com, www.costco.com, www.homedepot.com, www.therangehoodstore.com, www.overstock.com and www.wayfair.com. The gas ranges were sold from February 2019 through December 2022

The firm has received 44 reports of carbon monoxide emission, including three reports of consumers seeking medical attention.

This recall involves the oven compartment of ZLINE gas ranges with model numbers RG30, RGS-30, RGB-30, RG36, RGS-36, and RGB-36. The ranges were sold in various door colors including black matte, blue gloss, blue matte, DuraSnow, red gloss, red matte and white matte and multiple finishes including stainless steel, black stainless steel and DuraSnow, a cloudy steel finish. The recalled ranges were sold in two sizes, 30 inches and 36 inches. The ZLINE logo is printed on the bottom of the door. The model number is printed on a label on the back of the range. For ranges purchased after 2020, the model number is also printed on a label underneath the right side of the range top, visible when the oven door is open. Only ZLINE gas ranges with these model numbers are included in this recall.

Consumers should immediately stop using the oven compartment of the recalled ranges until a free repair is available. Consumers may continue to use the range tops which are unaffected by the issue. Contact ZLINE, who is working to develop repairs for all affected units.

In case you experience carbon monoxide poisoning symptoms, such as headache, weakness, dizziness, nausea or vomiting, shortness of breath, confusion, or blurred vision, from this product, it is important to report it. If symptoms persist, seek medical care.

Source: cpsc.gov
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Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two potential issues with CADDTM Infusion System Infusion Sets related to potential lack of delivery or underdelivery and false no disposable attached (NOA) alarms. The letter details the issues, the affected items, the... See More required steps to perform, and specific instructions for treatment of patients requiring life sustaining therapy.

The first issue, lack of delivery or underdelivery, may occur due to manufacturing variations that can potentially cause the green CADD Flow Stop arm to compress partially occlude the tubing before clinical use. If this happens, there is a potential that the occlusion does not resolve when the CADD reservoir or administration set is connected to the pump, and the pump may not detect the occlusion. This may result in underdelivery or non-delivery of medication, despite the pump displaying that the infusion is running properly.

The second issue, false "no disposable attached" (NOA) alarms, is specific to CADD-Legacy pumps, which Smiths Medical announced the discontinuation of sale effective December 37, 2022. There is a potential that CADD-Legacy pumps may not detect that 50 ml and 700 ml CADD Medication Cassette Reservoirs with Flow Stop are attached to the pump when they are properly attached. When this happens, the pump will initiate an NOA alarm if the NOA double-beep warning is not resolved within 2 minutes. The user must clear the alarm and resolve the cause of the NOA event before using the pump. This issue does not impact 250 ml Flow-Stop and non-Flow Stop CADD Medication Cassette Reservoirs.

In case you experience 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: Smith’s Medical
Brand name: Smith’s Medical
Product recalled: CADD Infusion System Infusion Sets for use with CADD pumps
Reason of the recall: Potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.
FDA Recall date: January 05, 2023

Source: fda.gov
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ZLINE recalled about 28,000 ZLINE gas ranges because the oven of the gas ranges can emit dangerous levels of carbon monoxide (CO) while in use, posing a serious risk of injury or death from carbon monoxide poisoning. These products were sold at Best Buy, Lowe’s, The Home... See More Depot, The Range Hood Store stores nationwide and online at www.bestbuy.com, www.build.com, www.costco.com, www.homedepot.com, www.therangehoodstore.com, www.overstock.com and www.wayfair.com. The gas ranges were sold from February 2019 through December 2022

The firm has received 44 reports of carbon monoxide emission, including three reports of consumers seeking medical attention.

This recall involves the oven compartment of ZLINE gas ranges with model numbers RG30, RGS-30, RGB-30, RG36, RGS-36, and RGB-36. The ranges were sold in various door colors including black matte, blue gloss, blue matte, DuraSnow, red gloss, red matte and white matte and multiple finishes including stainless steel, black stainless steel and DuraSnow, a cloudy steel finish. The recalled ranges were sold in two sizes, 30 inches and 36 inches. The ZLINE logo is printed on the bottom of the door. The model number is printed on a label on the back of the range. For ranges purchased after 2020, the model number is also printed on a label underneath the right side of the range top, visible when the oven door is open. Only ZLINE gas ranges with these model numbers are included in this recall.

Consumers should immediately stop using the oven compartment of the recalled ranges until a free repair is available. Consumers may continue to use the range tops which are unaffected by the issue. Contact ZLINE, who is working to develop repairs for all affected units.

In case you experience carbon monoxide poisoning symptoms, such as headache, weakness, dizziness, nausea or vomiting, shortness of breath, confusion, or blurred vision, from this product, it is important to report it. If symptoms persist, seek medical care.

Source: cpsc.gov
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SunSprout Enterprises is voluntarily recalling two lots (#4211 and 5211) of raw alfalfa sprouts in 4-ounce clamshells, with best-by dates between 12/10/22 and 12/27/22, due to potential contamination with Salmonella. The company directly distributed 808 pounds of product to five food service and grocery customers in Nebraska,... See More Kansas, and Iowa between late November and early December 2022. To date, SunSprout has received no complaints or reports of illness due to this recalled product.

The alfalfa sprouts are available in the produce section of grocery stores. The lot code and best buy date can be found on the front of the package. No other SunSprout lot codes or products are impacted by this voluntary recall. The raw alfalfa sprouts are packaged in 4-ounce clamshells with best buy dates between 12/10/2022 and 12/27/2022 and lot codes #4211 and 5211.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.

This voluntary recall is a result of a preliminary investigation by the State of Nebraska in connection with CDC of an outbreak of illness likely associated with alfalfa sprouts. SunSprout, out of an abundance of caution, is initiating this voluntary recall while it further investigates how this alfalfa product was handled and stored after it left its Nebraska facility.

Customers with product from this lot number in their possession should stop using it and dispose of it immediately. Consumers are also encouraged to follow all safe handling instructions and wash their hands and all preparation surfaces after handling any raw product.

In case you are experiencing Salmonella symptoms such as diarrhea, abdominal cramps, and fever, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: SunSprout Enterprises
Brand name: Sun Sprouts
Product recalled: Alfalfa Sprouts
Reason of the recall: Salmonella
FDA Recall date: December 29, 2022

Source: fda.gov
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Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single Dose Fliptop Vial, lot 33045BA, to the user level due to two visible glass particulates observed in a single vial. The product was distributed nationwide to wholesalers/hospitals/ institutions in the United States... See More and Puerto Rico from June 23, 2022 through September 19, 2022.

If administered intravenously, patients may experience adverse events such as local irritation or swelling, vasculitis/ phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. If administered orally or via a nasogastric tube, there may be the potential for gastrointestinal trauma. The risk is reduced by the possibility of detection, as the label contains a statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Pfizer has not received reports of any adverse events related to this recall. Vancomycin Hydrochloride is an antibiotic indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. Vancomycin Hydrochloride is effective in the treatment of staphylococcal endocarditis, septicemia, bone infections, lower respiratory tract infections, and skin and skin-structure infections. It is used in penicillin-allergic patients, and also for patients who cannot receive or who have failed to respond to other antimicrobials, including penicillin or cephalosporin agents, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobials.

The NDC, Lot Number, Expiration Date, and Configuration details for Vancomycin HCl for injection, USP are indicated below.

Product: Vancomycin Injection, USP, Single-Dose Fliptop Vial
NDC: Vial: 0409-3515-11 Carton: 049-3515-01
Lot Number: 33045BA
Expiration Date: 1SEP2023
Presentation: 1.5 g/Vial
Configuration/Count: 10 units/carton, 10 cartons/case

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers, hospitals, institutions, and doctors with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution, and quarantine immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product.

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. If symptoms persist, seek medical care.

Company name: Hospira, Inc.
Brand name: Hospira, Inc.
Product recalled: Vancomycin Injection
Reason of the recall: Presence of Visible Glass Particulates
FDA Recall date: December 27, 2022

Source: fda.gov
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Durham, North Carolina, Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level. This product is being recalled because Accord received... See More a product complaint report from a hospital pharmacy that vials labeled as “Daptomycin for Injection 500 mg/vial” were found in cartons labeled as “Daptomycin for Injection 350 mg/vial”. These products were distributed to wholesale nationwide in the USA.

The lot and expiration date printed on the outer carton and inner vial are the same and correspond to “Daptomycin for Injection 500 mg/vial.” Accordingly, Accord is voluntarily recalling all of lot #R2200232, Daptomycin for Injection 500 mg/vial, which may be in outer cartons that read “Daptomycin for Injection 500 mg/vial” OR “Daptomycin for Injection 350 mg/vial.” 

- Affected products:

Product: Daptomycin for Injection 500 mg/vial
NDC: 16729-435-05
Lot number/Expiration Date: R2200232, 01/2025

Product: Daptomycin for Injection 350 mg/vial
NDC: 16729-434-05
Lot number/Expiration Date: R2200232, 01/2025

Company name: Accord Healthcare, Inc
Brand name: Accord
Product recalled: Daptomycin for Injection
Reason of the recall: Mislabeling
FDA Recall date: December 27, 2022

Risk Statement: Administration of Daptomycin 500 mg/vial, to the population most at risk which are children or patients with renal impairment, there is a reasonable probability that the likelihood of the labeled warnings can potentially be increased if a higher than the intended dose is used which could lead to serious adverse health consequences. If these reactions occur, they may require medical treatment such as hemodialysis and systemic glucocorticoids. To date, Accord has not received any reports of adverse events related to this recall.

The product is used for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureaus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

The lot number, NDC number and expiration date of affected Daptomycin 500 mg/vial and Daptomycin 350 mg/vial product is shown below:

Product: Daptomycin for Injection 500 mg/vial
NDC: 16729-435-05
Lot number/Expiration Date: R2200232, 01/2025

Product: Daptomycin for Injection 350 mg/vial
NDC: 16729-434-05
Lot number/Expiration Date: R2200232, 01/2025

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. If symptoms persist, seek medical care.

Source: fda.gov
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Samsung recalled 663,500 Samsung Top-Load Washing Machines because they can short-circuit and overheat, posing a fire hazard. These products were sold by Best Buy, Costco, The Home Depot, Lowe’s and other appliance stores nationwide in the USA and online at Samsung.com from June 2021 through December 2022.... See More

The recalled products are the following models of Samsung’s top-load washers with super-speed wash:

- WA49B5105AV/US, Serial Number Range: 01J457BT700001W through 01J457BTB00111H
- WA49B5105AW/US Serial Number Range: 01J557BT700001J through 01J557BT700010D
- WA49B5205AW/US, Serial Number Range: 01HH57BT300006X through 01HH57BTB00932W
- WA50B5100AV/US, Serial Number Range: 01J257BT70001B through 01J257BTB01232B
- WA50B5100AW/US, Serial Number Range: 01J357BT770001L through 01J357BT700010F
- WA51A5505AC/US, Serial Number Range: 01HA57BR700003P through 01HA57BTB00346F
- WA51A5505AV/US, Serial Number Range: 01H257BR600003R through 01H257BTB02018L
- WA51A5505AW/US, Serial Number Range: 01GY57BR600026P through 01GY57BTB00269W
- WA52A5500AC/US, Serial Number Range: 01HB57BR700003Y through 01HB57BTB02968X
- WA52A5500AV/US, Serial Number Range: 01H357BR600006A through 01H357BTB01820Y
- WA52A5500AW/US, Serial Number Range: 01H457BR600003X through 01H457BTB01503Y
- WA54A7305AV/US, Serial Number Range: 01H557BR600003P through 01H557BR800650T
- WA55A7300AE/US, Serial Number Range: 01H057BR600001H through 01H057BTB05872Z
- WA55A7700AV/US, Serial Number Range: 01H157BR600151Z through 01H157ZT700005K

The washers were sold in white, black, champagne, and ivory colors.

Samsung has received 51 reports of smoking, melting, overheating, or fire involving the washers; 10 of which resulted in property damage. 3 consumers have reported injuries due to smoke inhalation.

Consumers should immediately check whether their washer’s software has been updated to prevent the hazard; and, if not, consumers should immediately stop using the washer until the software is updated. All Wi-Fi equipped washers that are plugged into a power source and actively connected to the internet will automatically download the free software repair over-the-air when they are connected to the internet. Consumers who have not connected their Wi-Fi equipped washer to the internet should contact Samsung for instructions on how to download the software repair.

Consumers whose washer does not have Wi-Fi capability or who otherwise wish to receive a free software repair without connecting to the internet, should immediately stop using the washer and contact Samsung directly for a free dongle to plug in and download the free software repair.

Source: cpsc.gov
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