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Imperia Elita Vitaccino Coffee - recalled due to Undeclared Sibutramine and Fluoxetine, USA

May 28, 2021 6:02 PM

United States

Company name: Dash Xclusive
Brand name: Imperia Elita
Product recalled: Imperia Elita Vitaccino Coffee
Reason of the recall: Undeclared Sibutramine and Fluoxetine
FDA Recall date: May 28, 2021
Recall details: Dash Xclusive is voluntarily recalling all lots of Imperia Elita Vitaccino Coffee to the consumer level. FDA analysis has found the product to contain undeclared sibutramine and fluoxetine. Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.

Fluoxetine is an FDA approved drug indicated for the treatment of various depressive disorders, obsessive compulsive disorder, bulimia and panic disorders. This drug product carries a box warning for suicidal thoughts and behaviors and it needs to be monitored closely by a prescriber.

The presence of sibutramine and fluoxetine in Imperia Elita Vitaccino coffee renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. Dash Xclusive has not received any reports of adverse events related to this recall.

Risk Statement: Products containing undeclared sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Products containing undeclared fluoxetine could cause suicidal thinking and behavior, an accumulation of high levels of serotonin in the body or neuroleptic malignant syndrome (NMS)-like reactions which is a life-threatening neurological disorder; elevated mood state that can cause higher than normal energy levels, restlessness, decreased need for sleep; abnormal bleeding, and low sodium levels.

The product is marketed as a dietary supplement for weight loss and is packaged in a black rectangular box and contains fifteen sachets. The affected Imperia Elita Vitaccino coffee lots include all lots. Product was distributed Nationwide in the USA via internet and by ebay at www.ebay.com.

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. Dash Xclusive is notifying its customers by e-messages on the eBay platform and is arranging for return of all recalled products. Consumers that have Imperia Elita Vitaccino Coffee which is being recalled should stop using/return to Dash Xclusive, PO BOX. #220, 1125 E. Broadway Glendale, California 91205.

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. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA

More incidents from:
Drugs
Recall
United States

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June 11, 2021 9:02 PM

“Company name: Viona Pharmaceuticals Inc.
Brand name: Viona Pharmaceuticals Inc.
Product recalled: Metformin Hydrochloride Extended-Release Tablets
Reason of the recall: Contains Nitrosodimethylamine (NDMA) impurities
FDA Recall date: June 11, 2021
Recall details: Viona Pharmaceuticals Inc., is... See Morevoluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India in November 2019, for U.S. distribution by Viona Pharmaceuticals Inc.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment.

According to the FDA, it could be dangerous for patients with this serious condition to stop taking their Metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information at fda.gov To date, neither Viona Pharmaceuticals Inc., nor Cadila Healthcare Limited have received any reports of adverse events related to this recall.

The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 72578-036-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are listed in the below table. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with "Z", "C" on one side and "20" on the other side. Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was distributed Nationwide to Distributors.

- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg. NDC No: 72578-036-01. Batch No: M915601. Exp. Date: Oct-2021.

Check the full recall details on fda.gov

Source: FDA
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June 11, 2021 10:00 PM

“Company name: Purina Animal Nutrition
Brand name: Purina
Product recalled: Beef Cattle Feed RangeLand® 30-13 TUB
Reason of the recall: Tubs that are too soft, allowing over-consumption which can lead to urea toxicity.
FDA Recall date: June 11, 2021
Recall details: Purina Animal Nutrition is ini... See Moretiating a very limited voluntary recall of one lot of Purina® RangeLand® 30-13 (125#) beef cattle feed. This recall is being initiated as a precaution related to tubs that are too soft, allowing over-consumption, which could result in urea toxicity.

Purina Animal Nutrition received reports from customers claiming the feed may have resulted in poor health and/or death. Elevated urea levels can cause health issues and potential death in cattle. Symptoms of excess urea may include muscle tremors (especially of the face and ears), abdominal pain, frothy salivation, polyuria, and bruxism (grinding of teeth). The affected product and lot number is:

- Formula No: L3B3. Item No: 1800049-627. Description: Purina® RangeLand® 30-13 (125#). Lot Number: 1MAR19CLF1

The affected feed was manufactured by Purina Animal Nutrition on March 19, 2021. The affected Purina® feed was sold in the following states: Arizona, Arkansas, Hawaii, Idaho, Louisiana, Mississippi, New Mexico, Oklahoma, Oregon, Texas, Washington.

Customers can find the lot number on the side of each tub. Customers who purchased this product are instructed to stop feeding and to destroy or return it to the point of purchase.

Check the full recall details on fda.gov

Source: FDA
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June 13, 2021 1:00 PM

“Company name: Freshpet Inc.
Brand name: Freshpet
Product recalled: Select Small Dog Bite Size Beef & Egg Recipe Dog Food
Reason of the recall: Potential for Salmonella
FDA Recall date: June 13, 2021
Recall details: Freshpet Inc. is announcing a voluntary recall of a single lot of Freshpet® Se... See Morelect Small Dog Bite Size Beef & Egg Recipe Dog Food (1 LB bags), with Sell by Date 10/30/2021,due to potential contamination with Salmonella. Our Freshpet Team had designated this single lot for destruction, but it was inadvertently shipped to retailers in limited geographic markets between June 7 to June 10, 2021. No other Freshpet products or lot codes are impacted 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. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Dogs with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some dogs will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy dogs can be carriers and infect other animals or humans. If your dog has consumed the recalled product and has these symptoms, please contact your veterinarian.

Freshpet has received no reports of illness, injury, or adverse reaction to date, and has issued this recall because of our deep commitment to the safety of our pet parents and their dogs. The limited number of impacted products may have been sold at: Publix in Florida, South Carolina, and Georgia, and at limited Target locations in Arizona and Southern California.

Most of the product was intercepted at retailer distribution warehouses and not delivered to retail stores. If pet parents have products matching the following description in their possession, they should stop feeding it to their dogs and dispose of it immediately.  

Please see the product pictures and the information below for details.

- Product Name: FRESHPET® SELECT SMALL DOG BITE SIZE BEEF & EGG RECIPE
- Retail UPC Code: 627975012939
- Lot Code: 1421FBP0101
- Sell-by Date: 10/30/2021 L2

Check the full recall details on fda.gov

Source: FDA
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June 15, 2021 8:00 PM

“Company name: Fold Hill Foods
Brand name: Fold Hill Food
Product recalled: Applaws Cat Dry Chicken, Applaws Cat Dry Chicken & Salmon, AVA Adult Fish, AVA Adult Mature Chicken 7+, AVA Senior Chicken 12+, AVA Sensitive Skin & Stomach, AVA Weight Management, AVA Hairball, AVA Oral Care, AVA British S... See Morehorthair, AVA Persian, AVA Maine Coon, Applaws Kitten Dry Chicken, by Sainsbury’s Hypoallergenic Recipe complete dry cat food with Salmon 1+ Years, by Sainsbury’s Hypoallergenic Recipe complete dry cat food with Chicken 1+ Years, Applaws Cat Dry Chicken & Lamb, Applaws Cat Dry Chicken & Duck, Applaws Cat Dry Ocean Fish, Applaws Cat Dry Senior Chicken, Product, AVA Kitten Chicken, AVA Adult Chicken
FSA Recall date: 06/15/2021
Recall details: Fold Hill Foods is taking the precautionary action of recalling several hypoallergenic cat food products because of safety concerns.

- Applaws Cat Dry Chicken (400g, 2kg and 7.5kg)
- Applaws Cat Dry Chicken & Salmon (400g, 2kg and 7.5kg)
- AVA Adult Fish (2kg)
- AVA Adult Mature Chicken 7+ (2kg and 4kg)
- AVA Senior Chicken 12+ (2kg)
- AVA Sensitive Skin & Stomach (1.5kg)
- AVA Weight Management (1.5kg)
- AVA Hairball (1.5kg)
- AVA Oral Care (1.5kg)
- AVA British Shorthair (1.5kg)
- AVA Persian (1.5kg)
- AVA Maine Coon (1.5kg)
- Applaws Kitten Dry Chicken (400g, 2kg and 7.5kg)
- by Sainsbury’s Hypoallergenic Recipe complete dry cat food with Salmon 1+ Years (800g)
- by Sainsbury’s Hypoallergenic Recipe complete dry cat food with Chicken 1+ Years (800g)
- Applaws Cat Dry Chicken & Lamb (400g, 2kg and 7.5kg)
- Applaws Cat Dry Chicken & Duck (400g, 2kg and 7.5kg)
- Applaws Cat Dry Ocean Fish (350g, 1.8kg and 6kg)
- Applaws Cat Dry Senior Chicken (400g, 2kg and 7.5kg)
- AVA Kitten Chicken (300g and 2kg)
- AVA Adult Chicken (300g, 2kg and 4kg)

Check the full detailed list of the recalled products in the link below.

If you have bought any of the above products you should stop feeding them to your cat. If cat owners are concerned about the health of their pet then they should seek immediate advice from their vet.

There has been an increase in cases of pancytopenia in cats and there is a possible link to the cat food products listed above. Pancytopenia is a very rare condition wherein the number of blood cells (red, white, and platelets) rapidly decreases, causing serious illness.

Check the full recall details on food.gov.uk

Source: FSA
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June 15, 2021 7:00 PM

“Company name: Philips
Brand name: Philips
Product recalled: Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices
Reason of the recall: Potential health risks related to the polyester-based polyurethane (PE-PUR) so... See Moreund abatement foam component in these devices
FDA Recall date: June 15, 2021
Recall details:
- Philips is initiating a voluntary recall notification* to ensure patient safety in consultation with regulatory agencies
- Corrective actions include the deployment of updated instructions for use and a repair and replacement program for affected devices
- Philips aims to address all affected devices within the scope of this correction as expeditiously as possible.

Amsterdam, the Netherlands – Following the company update on April 26, 2021, Royal Philips(NYSE: PHG; AEX: PHIA) today provides an update on the recall notification* for specific Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. The majority of the affected devices within the advised 5-year service life are in the first-generation DreamStation product family.

To date, Philips has produced millions of Bi-Level PAP, CPAP and mechanical ventilator devices using the PE-PUR sound abatement foam. Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone,** and high heat and high humidity environments may also contribute to foam degradation.

Therefore, Philips has decided to voluntarily issue a recall notification* to inform patients and customers of potential impacts on patient health and clinical use related to this issue, as well as instructions on actions to be taken.

Recall notification* advise for patients and customers. Based on the latest analysis of potential health risks and out of an abundance of caution, the recall notification* advises patients and customers to take the following actions:

- For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.*

- For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.*

Possible health risks: The company continues to monitor reports of potential safety issues as required by medical device regulations and laws in the markets in which it operates. To date, there have been no reports of death as a result of these issues.

Philips has received reports of possible patient impact due to foam degradation. The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.

The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. Philips has received no reports regarding patient impact related to chemical emissions.

*This is a recall notification for the US only, and a field safety notice for the rest of the world
**Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication.

Check the full recall details on fda.gov

Source: FDA
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June 16, 2021 8:00 PM

“Company name: Fold Hill Foods
Product recalled: Applaws Cat Dry Chicken, Applaws Cat Dry Chicken & Salmon, AVA Adult Mature Chicken 7+, AVA Senior Chicken 12+, AVA Sensitive Skin & Stomach, AVA Weight Management, AVA Hairball, AVA Oral Care, AVA British Shorthair, AVA Persian, AVA Maine Coon, by Sa... See Moreinsbury’s Hypoallergenic Recipe complete dry cat food with Salmon 1+ Years, Applaws Kitten Dry Chicken, by Sainsbury’s Hypoallergenic Recipe complete dry cat food with Chicken 1+ Years, Applaws Cat Dry Chicken & Lamb, Applaws Cat Dry Chicken & Duck, Applaws Cat Dry Ocean Fish, Applaws Cat Dry Senior Chicken, AVA Kitten Chicken, AVA Adult Chicken, AVA Adult Fish
FSA Recall date: 06/16/2021
Recall details: Fold Hill Foods is taking the precautionary action of recalling several hypoallergenic cat food products because of safety concerns. This product recall information notice has been updated to include all best before dates for Applaws products with the site code GB218E5009. This is not due to the identification of further safety concerns, but is a voluntary action by the manufacturer to make things easier for consumers to understand which products have been affected.

- Applaws Cat Dry Chicken (400g, 2kg and 7.5kg)
- Applaws Cat Dry Chicken & Salmon (400g, 2kg and 7.5kg)
- AVA Adult Mature Chicken 7+ (2kg and 4kg)
- AVA Senior Chicken 12+ (2kg)
- AVA Sensitive Skin & Stomach (1.5kg)
- AVA Weight Management (1.5kg)
- AVA Hairball (1.5kg)
- AVA Oral Care (1.5kg)
- AVA British Shorthair (1.5kg)
- AVA Persian (1.5kg)
- AVA Maine Coon (1.5kg)
- by Sainsbury’s Hypoallergenic Recipe complete dry cat food with Salmon 1+ Years (800g)
- Applaws Kitten Dry Chicken (400g, 2kg and 7.5kg)
- by Sainsbury’s Hypoallergenic Recipe complete dry cat food with Chicken 1+ Years (800g)
- Applaws Cat Dry Chicken & Lamb (400g, 2kg and 7.5kg)
- Applaws Cat Dry Chicken & Duck (400g, 2kg and 7.5kg)
- Applaws Cat Dry Ocean Fish (350g, 1.8kg and 6kg)
- Applaws Cat Dry Senior Chicken (400g, 2kg and 7.5kg)
- AVA Kitten Chicken (300g and 2kg)
- AVA Adult Chicken (300g, 2kg and 4kg)
- AVA Adult Fish (2kg)

If you have bought any of the above products you should stop feeding them to your cat. If you have bought an AVA product contact www.petsathome.com and fill out the contact form on the help page or livechat. If you have bought an Applaws product contact www.applaws.com/uk/contact-us. If you have bought a Sainsbury’s product contact www.sainsburys.co.uk/help or their Customer Careline on 0800 636262. If cat owners are concerned about the health of their pet then they should seek immediate advice from their vet.

There is concern on the safety of the products listed above. There has been an increase in cases of pancytopenia in cats and there is a possible link to the cat food products listed above. Pancytopenia is a very rare condition wherein the number of blood cells (red, white, and platelets) rapidly decreases, causing serious illness.

Check the full recall details on food.gov.uk

Source: FSA
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June 17, 2021 10:00 PM

“Company name: Smiths Medical
Brand name: Jelco
Product recalled: Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Reason of the recall: Skewed odd number line graduation markings on syringe barrels.
FDA Recall date: June 17, 2021
Recall details: Company Announcement Smiths Medical has become... See Moreaware of specific models and lots of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. Markings skewed approximately 20 degrees upward have been identified. Affected Models and Lot Numbers:

- Model Number: 4428-1
- Name: Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 28Gx1/2” 1CC
- Lot Number: 4046543 and 4062235

- Model Number: 4429-1
- Name: Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe 29Gx1/2” 1CC
- Lot Number: 4014096, 4031846, 4031845, 4040734, 4043536, 4046545, 4046546, 4062239, 4062240, 4062238 and 4062242

Please reference the attachment for an illustration of the skewed graduation marking on the syringe barrel.

As a result of this issue, there is potential for administration of an incorrect dose of insulin, which could result in hyperglycemia (which may lead to ketoacidosis) or hypoglycemia (which may lead to seizures). This may result in serious harm or death.

Home Healthcare Environments: the lot number can be found on the packaging for the syringe. Do not use any syringes with the affected lot numbers. The patient or caretaker should contact the pharmacy, home healthcare provider or medical facility that provided the syringe to arrange for return of the syringe and replacement.

Check the full recall details on fda.gov

Source: FDA
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June 18, 2021 3:16 PM

“Health Canada announced the recall of Natural Balance L.I.D. Green Pea & Chicken Dry Cat Formula by Natural Balance Pet Foods, Inc. due to possible contamination with Salmonella. As of June 2, 2021, the company has not received any reports of illness, complaints, or injuries in Canada.

Recalled c... See Moreat formula products are:

- Natural Balance L.I.D. Limited Ingredient Diets® Green Pea & Chicken Formula Dry Cat Food- 5 LB Bag, Case Item Code: 2363300234, UPC: 2363300233, Lot 1008080 N811202-20, Best If Used by Date 10-Mar-2022.
- Natural Balance L.I.D. Limited Ingredient Diets® Green Pea & Chicken Formula Dry Cat Food- 10 LB Bag, Case Item Code: 2363300235, UPC: 2363300235, Lot 1008080 N811202-20, Best If Used by Date 10-Mar-2022.

Product packaging is teal coloured with dark blue accents and lettering. Product lot code and Best If Used by Dates are printed on each package. This information can be found on the back panel of each 5lb and 10lb bag.

These products were manufactured in the United States by Diamond Pet Foods and distributed in Canada by Natural Balance Pet Foods, Inc. The company reported that 378 units of the affected product were sold from February 2021 to April 2021 in Canada.

The recalled cat formula may be contaminated with Salmonella and there is risk of cross contamination and illness after handling the cat formula. Symptoms of Salmonella infection in cats may include vomiting, diarrhea, decreased appetite, fever, or excessive salivation. Some cats may not appear sick but can spread infection to other animals and humans in the household

Consumers should immediately stop feeding any of the cat formula affected by this recall to cats and dispose of it immediately or return it to their retailer for a refund. Natural Balance Pet Foods products are 100% guaranteed and all returned products will be refunded.

For more details of this recall check: healthycanadians.gc.ca

Source: Health Canada
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“Company name: Purina Animal Nutrition
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Product recalled: Beef Cattle Feed RangeLand® 30-13 TUB
Reason of the recall: Tubs that are too soft, allowing over-consumption which can lead to urea toxicity.
FDA Recall date: June 11, 2021
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- Formula No: L3B3. Item No: 1800049-627. Description: Purina® RangeLand® 30-13 (125#). Lot Number: 1MAR19CLF1

The affected feed was manufactured by Purina Animal Nutrition on March 19, 2021. The affected Purina® feed was sold in the following states: Arizona, Arkansas, Hawaii, Idaho, Louisiana, Mississippi, New Mexico, Oklahoma, Oregon, Texas, Washington.

Customers can find the lot number on the side of each tub. Customers who purchased this product are instructed to stop feeding and to destroy or return it to the point of purchase.

Check the full recall details on fda.gov

Source: FDA
See Less

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