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Novo Nordisk Product Samples - recalled due to improper storage temperature, USA

May 10, 2021 4:00 PM

United States

Company name: Novo Nordisk
Brand name: Levemir, Tresiba, Fiasp, Novolog and Xultophy
Product recalled: Product Samples
Reason of the recall: Due to improper storage temperature conditions
FDA Recall date: May 10, 2021
Recall details: Novo Nordisk is voluntarily recalling 1,468 product samples listed in the table below of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements.

This recall only impacts product samples and does not impact product that has been broadly distributed to pharmacies or mail-order services. If product samples are exposed to temperatures below 32°F, it could cause a lack of efficacy and damage to the cartridge and pen-injectors. If product from an improperly stored vial, cartridge or pen-injector is used, there is a risk that you might not receive the right amount of medicine as intended which may lead to hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening.

Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall. These products are used to lower blood glucose levels in people with diabetes and are packaged in cartons with either a vial, pen-injector (FlexPen® or FlexTouch®) or a cartridge (PenFill®). A list of the affected lots can be found in the link below.

The product can be identified by looking for the batch number or lot number located on the product or carton and matching it to the list above. Novo Nordisk has notified all physician offices that received affected samples and requested all impacted samples be returned. Customers who received an affected sample through the physician’s office should have received a letter from their physician.

If product samples match a batch number or there are any questions about the recall, please contact the Novo Nordisk recall processor Inmar at 1-888-686-5002, Monday through Friday, 9:00 AM to 5:00 PM EDT. Please report any complaints and adverse events to Novo Nordisk's Customer Care Center which can be reached at 1-800-727-6500, Monday through Friday, 8:30 AM to 6:00 PM EDT.

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.

Check the full recall details on fda.gov

Source: FDA

More incidents from:
Drugs
Recall
United States

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May 25, 2021 4:00 PM

“Company name: Global Sanitizers
Brand name: Medically Minded
Product recalled: Hand Sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: May 25, 2021
Recall details: This is to inform you of a product recall involving: Medically Minded Hand Sanitizers: 8 oz. UPC 676753004208; L... See Moreot E332020, Lot E212020, and Lot E082020 8.5 oz. UPC 676753004147; Lot E372020 10 oz. UPC 676753004178 Lot GV4420205.

This recall has been initiated due to the presence of undeclared Methanol. Use of or consumption of this product can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma & or permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

Methanol was discovered through lab testing. To date, Global Sanitizers has not received any reports of adverse events related to this recall. We began shipping this product on approximately July 10, 2020. Immediately examine your inventory and quarantine product subject to recall.

In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.

If you have these recalled items in stock, please send an email to recall@globalsanitizers.com and we provide further instructions for product destruction. This recall should be carried out at the consumer level. This recall is being made with the knowledge of the Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less

May 28, 2021 6:02 PM

“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... See Morethe 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
See Less

June 3, 2021 1:00 PM

“Company name: Sunshine Mills, Inc.
Brand name: Sportsman’s Pride, Sprout Sporting, Intimidator, FRM Gold Select
Product recalled: Dog Food Products
Reason of the recall: Salmonella contamination
FDA Recall date: June 03, 2021
Recall details: Sunshine Mills, Inc. is issuing a voluntary recall o... See Moref certain dog food products because of the potential to be contaminated with Salmonella. No illnesses, injuries or complaints have been reported to date. The potential for contamination was noted after the firm was notified by the distributor, Fleet Wholesale Supply Company, who was informed by Minnesota Department of Agriculture when a sample of 5 lbs.

Sprout Sporting Dog Food product was collected and tested positive for Salmonella during routine surveillance. Salmonella can affect animals eating the products 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. Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans.

If your pet has consumed a recalled product and has these symptoms, please contact your veterinarian.

The best buy date and lot code can be found on the back of each package. The products identified below were distributed online and in retail stores:

- Sportsman's Pride Professional Formula 30/20 Dog Food (40 lb.). BB Date Code & Lot: Best if used By 7 Oct 2021. Lot: TI1 07/Oct/2020. UPC Code: 7015510184. States MS, FL, TN, LA, VA, NC, TX.

- Sprout Sporting Dog Food (5 lb.). BB Date Code & Lot: Best if used By 6 Oct 2021. Lot: TE1 06/Oct/2020. UPC Code: 7015505101. States MN, WI, IA, SD, ND.

- Sprout Sporting Dog Food (40 lb.). BB Date Code & Lot: Best if used By 6 Oct 2021. Lot: TI3 06/Oct/2020. UPC Code: 7015505100. States MN, WI, IA, SD, ND.

- Intimidator Chicken & Rice FormulaDog Food 30/20 (16 lb.). BB Date Code & Lot: Best if used By 6 Oct 2021. Lot: TA1 06/Oct/2020. UPC Code: 7015541002. States TX, MS, FL, AL.

- Intimidator Chicken & Rice FormulaDog Food 30/20 (40 lb.). BB Date Code & Lot: Best if used By 6 Oct 2021. Lot: TA1 06/Oct/2020. UPC Code: 5216631214. States TX, MS, FL, AL.

- FRM Gold Select High-Performance Dog Food (50 lb.). BB Date Code & Lot: Best if used By 6 Oct 2021. . UPC Code: 1549905873. States GA, FL.

Check the full recall details on fda.gov

Source: FDA
See Less

June 8, 2021 10:00 PM

“Company name: Hubbard Feeds
Brand name: Hubbard Feeds
Product recalled: EASY FEED ORGANIC CHICK STARTER/GROWER ORG
Reason of the recall: Contains deficient levels of salt
FDA Recall date: June 08, 2021
Recall details: Hubbard Feeds is voluntarily recalling EASY FEED ORGANIC CHICK STARTER/GROWER... See MoreORG with batch number B01785781. The product has been found to contain deficient levels of salt. Low sodium may cause abnormal nerve impulses so chicks’ muscles will not move well. Low sodium can also affect the cell’s normal internal pressure which can affect cardiac output due to deflated muscle not working well. The growth of birds may also be negatively impacted.

This recall relates only to EASY FEED ORGANIC CHICK STARTER/GROWER ORG distributed in the state of Colorado, with the following batch number printed on the package:

- Product Name: Easy Feed Organic Chick Starter/Grower Org
- Batch/Lot#: B01785781
- Item No./Product No.: 53266
- Package Info.:40# Bag

Check the full recall details on fda.gov

Source: FDA
See Less

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“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... See Morethe 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
See Less

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May 25, 2021 4:00 PM

“Company name: Global Sanitizers
Brand name: Medically Minded
Product recalled: Hand Sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: May 25, 2021
Recall details: This is to inform you of a product recall involving: Medically Minded Hand Sanitizers: 8 oz. UPC 676753004208; L... See Moreot E332020, Lot E212020, and Lot E082020 8.5 oz. UPC 676753004147; Lot E372020 10 oz. UPC 676753004178 Lot GV4420205.

This recall has been initiated due to the presence of undeclared Methanol. Use of or consumption of this product can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma & or permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

Methanol was discovered through lab testing. To date, Global Sanitizers has not received any reports of adverse events related to this recall. We began shipping this product on approximately July 10, 2020. Immediately examine your inventory and quarantine product subject to recall.

In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter.

If you have these recalled items in stock, please send an email to recall@globalsanitizers.com and we provide further instructions for product destruction. This recall should be carried out at the consumer level. This recall is being made with the knowledge of the Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less

May 17, 2021 4:00 PM

“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Hand sanitizer
Reason of the recall: Product is contaminated with Burkholderia contaminants
FDA Recall date: May 17, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan is updating its previously anno... See Moreunced voluntary recall of Durisan Non-Alcohol Antimicrobial Hand Sanitizer products that became contaminated with a common municipal water supply-borne bacteria, Burkholderia contaminants. Use of a hand sanitizer contaminated with Burkholderia contaminants, generally considered to be of low virulence, can range from no reaction to possible infections in a person with a hand-wound or scrapes because the bacteria could enter the bloodstream, especially in patients with compromised immune systems.

In the April 10, 2021 announcement, Durisan expanded the recall to include all of its Hand Sanitizer products that had not expired (produced after 4/10/2019). Durisan discovered that promotional orders, as well as small run production lot numbers which were not listed, were intended for inclusion in the recall. For clarification, in the link below are all affected lot numbers.

Customers or consumers in possession of Durisan Non Alcohol Antimicrobial Hand Sanitizer products with these numbers in any form factor are encouraged to contact Durisan. To date, no qualified reports of adverse reactions have been reported related to this recall. The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available.

The product is packaged in sizes ranging from 18mL credit cards, to bottles sized in 118, 236, 300 and 550 mL and 1000mL wall mounted dispenser refills. At this time, we are including lot numbers of promotional orders, wipes, and private label products. The lot number can be found in black print on the bottom of the package. Durisan Antimicrobial Solutions hand sanitizer sizes with the identification are listed in the link below.

Durisan has provided written notification to its distributors and retailers and is alerting consumers via this voluntary recall. Consumers that have the product are advised to contact Durisan to return it. 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
See Less

May 19, 2021 1:00 PM

“Company name: Dibar Nutricional S. de R.L. de C.V.
Brand name: DIBAR Labs, ProtectoRx
Product recalled: Hand Sanitizer
Reason of the recall: Presence of methanol
FDA Recall date: May 19, 2021
Recall details: Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (“Dibar”) is voluntari... See Morely recalling all Dibar Labs Hand Sanitizer packaged in 8oz and 16 oz bottles, respectively, to the consumer level (see Label 1 below). Dibar is also voluntarily recalling ProtectoRx Hand Sanitizer packaged in 2oz and 16oz fluid ounce bottles, respectively, to the consumer level (see Label 2 below), as well as all Advance Hand Sanitizer packaged in 16 oz bottles, likewise, to the consumer level (see Label 3 below). These products are being recalled after testing conducted by our firm revealed the presence of methanol.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest the products and adolescents and adults who drink the products as an alcohol (ethanol) substitute are most at risk for methanol poisoning.

To date, the company has not received any reports of adverse reactions related to this recall. These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available.

The affected bottles of hand sanitizer include a twelvedigit lot code printed on the bottle near the base. The products can be identified by the label image provided at the end of this release. Products labeled as Dibar Labs Hand Sanitizer were distributed nationwide in the USA through S.E.N.D. LLC and its customers. Products labeled as ProtectoRx Hand Sanitizer were distributed in Puerto Rico through PR TRADING LLC and its customers. Products labeled as Advance Hand Sanitizer were distributed in the USA through RGV HEALTH SERVICES LLC DBA VALLEY and its customers.

Dibar Nutricional S. de R.L. De C.V., has notified its direct distributors by letter and asked that they remove the recalled products from commerce immediately if they still possess inventory.

Consumers, distributors and retailers that have the hand sanitizers which are being recalled should stop using, distributing and/or selling them and return them to the place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this 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. Link to Original Recall

Check the full recall details on fda.gov

Source: FDA
See Less