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Blood

Updated:

Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. The product lots were distributed nationwide to wholesalers, Distributors and Retailers (dispensers) … See More
in the United States from June 2022 to October 2022. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.

The NDC. Lot Number. Expiration Date. and Packaging Configuration details for Dabigatran Etexilate Capsules that are subjected to this recall are shown in the image below.

In case you experience 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: Ascend Laboratories LLC.
Brand name: Ascend Laboratories
Product recalled: Dabigatran Etexilate Capsules, USP
Reason of the recall: Detection of N-Nitrosodimethylamine (NDMA) Impurity
FDA Recall date: March 22, 2023

Source: www.fda.gov
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#blood #drugs #us

W
I was working there and only last a couple weeks. The filth. I’ve never seen a place of business especially one where food is being handled. In the far back cooler the is raw meet over cooked meat. The amount of rotting blood on the floor was so gross. And owner does not care

#raw #blood #cleanliness #foodsafetyissue #510mainstreet #humboldt #saskatchewan #ca

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Life2000 Ventilation System due to the potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator. … See More
The Life2000 system is manufactured by Hillrom, which was acquired by Baxter in late 2021. The Life2000 System is distributed in the United States.

Low oxygen saturation may lead to symptoms such as shortness of breath, confusion, rapid heart rate or bluish skin. Among the most vulnerable patients, death, life-threatening events or permanent impairment may occur if patients or caregivers do not recognize lower oxygen levels. Scenarios that could lead to oxygen desaturation include hoses that are kinked or have excessive moisture; modified, extended or loose/disconnected tubing; oxygen liter flow from the concentrator that has fallen below the prescribed level while using the Life2000 system; and/or non-compliance with recommended cleaning and maintenance of the Life2000 system and oxygen concentrator. Baxter has received reports of patient desaturation that required hospitalization. Based on analysis to date, no deaths have been reported related to this issue.

As described in the Urgent Medical Device Correction issued on January 25, 2023, patients can continue to use the Life2000 system if they follow daily checks and preventive maintenance requirements as detailed in the patient letter and Instructions for Use for both the Life2000 Ventilation System and third-party oxygen concentrators. These actions will help ensure the best oxygen delivery with the Life2000 system when used with a third-party oxygen concentrator. Baxter is continuing to monitor and investigate reports received and is currently investigating improvement opportunities.

Baxter will issue a follow-up letter to patients to communicate further details on the actions being taken to address this issue. This Urgent Medical Device Correction applies to all Life2000 Ventilation Systems used with an oxygen concentrator, including the Life2000 Ventilator Packaged (BT-20-0002); the Life2000 Ventilator Packaged A (BT-20-0002A); the Life2000 System AC Package (BT200007); the Breathe Life2000 Ventilator PA (BT-20-0007); the Life2000 System HC Package (BT200011); the Breathe Technology Life2000 VE (BT-20-0011); and the Life2000 Ventilator V6.X (MS-01-0118).

Baxter is voluntarily issuing this Urgent Medical Device Correction and the U.S. Food and Drug Administration has been notified of this action.

Company name: Baxter International Inc.
Brand name: Life2000
Product recalled: Life2000 Ventilation System
Reason of the recall: Potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator
FDA Recall date: March 10, 2023

Source: www.fda.gov
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#blood #recall #medicaldevices #us #pita

H

PRO Apixiban by Pro Doc, South Shore, QC, Canada

1 year ago reported by user-hhkgt152

Was given a generic to Eliquis blood thinner called PRO Apixiban. The government will no longer cover Eliquis and it’s a life essential medication. But, sending billions overseas makes more sense.
One dose made me very ill for 22 days. It started with heart burn, gas, then … See More
nausea hit and persisted 24/7 for 22 days. The company Pro Doc makes this and is either owned by Jean Coutu or they are affiliated. It felt like poison in my body and hope no damages were done. My heart burn persists but the nausea has subsided finally. Not even Gravol helped me. I lost almost a month to this. When they tell you generic is the same, they are lying.
I will report to Health Canada shortly.  | Symptoms: Nausea, Heartburn
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#blood #medicaldevices #quebeccity #quebec #ca #sub #ro-tel

Bindle Bottle LLC of Carlsbad, CA, is recalling its Bindle Bottles because they may contain an area of exposed lead located in the bottom storage compartment of the bottle. Unpackaged food stored in the bottom storage compartment of the bottle may have been adulterated by the lead … See More
and could pose health problems to people or animals eating that adulterated food. The recalled Bindle Bottles were distributed nationwide via bindlebottle.com, amazon.com, promotional distributors, and in retail stores. No illnesses have been reported to date in connection with this problem.

The product comes in four sizes: 32 oz, 24 oz, 20 oz, and 13 oz. Bindle Bottle is also recalling the 24 oz bottle that is part of the Puppy Pack.

People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning. If a child is exposed to enough lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system can occur. This can result in learning disorders, developmental defects, and other long-term health problems. Clinical signs in dogs with acute lead poisoning may include lethargy, anorexia, behavioral changes, ataxia (wobbly gait), tremors, and seizures.

Reports by Lead Free Mama and Consumer Reports led the firm to have the bottle tested. The recall was initiated after analytical results revealed that the small, 0.4” diameter soldering dot in the bottom storage compartment contained lead. Subsequent investigation indicates the problem was caused by a lack of a cover or barrier to the exposed soldering dot. Production of Bindle Bottles has been suspended and will be overhauled going forward, eliminating the presence of exposed lead anywhere on future products. As part of the recall, consumers who purchased a Bindle Bottle are eligible to receive at-home repair kits to rectify the issue. These repair kits can be obtained by filling out a form at bindlebottle.com/pages/recall.

In case you experience 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: Bindle Bottle LLC
Brand name: Bindle Bottle LLC
Product recalled: Bottles
Reason of the recall: Adulterated by lead
FDA Recall date: February 23, 2023

Source: www.fda.gov
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#blood #recall #us #sub #chi-chis

Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level. FDA analysis has found PrimeZen Black 6000 capsules to be tainted with sildenafil & tadalafil. Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment … See More
of male erectile dysfunction. The presence of sildenafil, tadalafil in PrimeZen Black 6000 capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall. Volt Candy has not received reports of state adverse events or injuries to date. The product was distributed Nationwide to consumers online.

Risk Statement: PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products.

PrimeZen Black 6000 is marketed as a dietary supplement for male enhancement and is packaged in a blister card with one capsule, UPC code: 728175521891. The affected PrimeZen Black 6000 includes the following lot number [NPINPB 1003] with an expiration date of 08/16/2025. The product can be identified by the card color in black with the name on it PrimeZen Black 6000. See the pictures attached.

Volt Candy is notifying their online customers by email and is arranging for return of all recalled products. Consumers or those with product in their possession should stop using and return the affected product PrimeZen Black 6000, lot number [NPINPB 1003] Expiration date 08/16/2025 to this address: Volt Candy 324 S. Diamond Bar Blvd #212.

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. If symptoms persist, seek medical care.

Company name: Volt Candy
Brand name: PrimeZEN
Product recalled: PrimeZEN Black 6000 male enhancement capsules
Reason of the recall: Product contains undeclared tadalafil and sildenafil
FDA Recall date: February 13, 2023

Source: www.fda.gov
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#blood #recall #drugs #us #sub

Update March 21, 2023

As of March 14, 2023, CDC, in partnership with state and local health departments, identified 68 patients in 16 states (CA, CO, CT, FL, IL, NC, NJ, NM, NY, NV, PA, SD, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively … See More
drug-resistant P. aeruginosa. 37 patients were linked to four healthcare facility clusters. 3 people have died and there have been 8 reports of vision loss and 4 reports of enucleation (surgical removal of eyeball). Dates of specimen collection were from May 2022 to February 2023. Isolates have been identified from clinical cultures of sputum or bronchial wash (15), cornea (17), urine (10), other nonsterile sources (4), and blood (2), and from rectal swabs (26) collected for surveillance; some patients had specimens collected from more than one anatomic site.

The investigation is ongoing.

Source: CDC

February 07, 2023

The CDC is collaborating with the FDA and state and local health departments to investigate a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa which has identified artificial tears as a common exposure for many patients. The outbreak strain, carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA), had never been reported in the United States prior to this outbreak.

As of January 31, 2023, CDC, in partnership with state and local health departments, identified 55 patients in 12 states (CA, CO, CT, FL, NJ, NM, NY, NV, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. 35 patients were linked to 4 healthcare facility clusters. 1 person has died and there have been 5 reports of vision loss. Dates of specimen collection were from May 2022 to January 2023. Isolates have been identified from clinical cultures of sputum or bronchial wash (13), cornea (11), urine (7), other nonsterile sources (4), and blood (2), and from rectal swabs (25) collected for surveillance; some patients had specimens collected from more than one anatomic site.

Patients reported over 10 different brands of artificial tears and some patients used multiple brands. EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the brand most commonly reported. This was the only common artificial tears product identified across the four healthcare facility clusters. Laboratory testing by CDC identified the presence of VIM-GES-CRPA in opened EzriCare bottles from multiple lots. CDC and FDA recommend clinicians and patients stop using EzriCare or Delsam Pharma’s Artificial Tears products pending additional guidance from CDC and FDA.

At this time, there is no recommendation for testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.

Eye infection symptoms may include:
- Yellow, green, or clear discharge from the eye
- Eye pain or discomfort
- Redness of the eye or eyelid
- Feeling of something in your eye (foreign body sensation)
- Increased sensitivity to light
- Blurry vision

In case you experience harm after using 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: www.cdc.gov
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#blood #us

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