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DIBAR Labs, ProtectoRx Hand Sanitizer - recalled due to presence of methanol, USA

May 19, 2021 1:00 PM

United States

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 voluntarily 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

More incidents from:
Drugs
Recall
Hand Sanitizer
United States

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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
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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
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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
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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
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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
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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 14, 2021 3:33 PM

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“Company name: Sunshine Mills, Inc.
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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:

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- 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
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June 10, 2021 10:20 AM

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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

June 7, 2021 11:39 AM

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Reported By SafelyHQ.com User

June 2, 2021 8:41 PM

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Bate and switch, Beckley, WV, Beckley, WV, USA

Beckley, WV, Beckley, WV, USA

June 11, 2021 4:27 PM

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June 3, 2021 6:32 PM

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June 5, 2021 8:25 PM

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Reported By SafelyHQ.com User