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Dibar Nutricional S. de R.L. de C.V. Hand Sanitizer - recalled due to Presence of methanol, USA

May 12, 2021 8:00 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 12, 2021
Recall details: Company Announcement Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (“Dibar”) is voluntarily recalling 27 lots of DIBAR Labs Hand Sanitizer packaged in 8oz (8-53090-00301-3 UPC) and 16 oz (8-53090-00302-0 UPC) fluid ounce bottles, respectively, to the consumer level. (See products listed in the link below in Table 1 and Label 1). Dibar is also voluntarily recalling 2 lots of ProtectoRx Hand Sanitizer packaged in 2oz (Lot Number LDHSN050720) and 16oz (Lot Number LDHSN050820) fluid ounce bottles, respectively, to the consumer level. (See products listed in the link below in Table 2 and Label 2). 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, scent, and lot code provided in the table at the end of this release. These products were distributed nationwide in the USA through S.E.N.D. LLC and its customers (Click in the link below Table 1). Products labeled as ProtectoRx Hand Sanitizer were distributed in Puerto Rico through PR TRADING LLC and its customers (Click in the link below Table 2.). Dibar Nutricional S. de R.L. De C.V., has notified its direct distributors by a letter with confirmatory email and asked that they remove the recalled products from commerce immediately if they still had any in 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 with questions regarding this recall can contact our Commercial Offices, +52 443-314-5369, M-F, during business hours 9:00 a.m. – 6:00 p.m. ET and/or email us to QA@dibarlabs.com.  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.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. (Table 1. Lots distributed to S.E.N.D. LLC and its customers)  

Check the full recall details on fda.gov

Source: FDA

More incidents from:
Drugs
Recall
United States

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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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June 22, 2021 1:00 PM

“Company name: Prairie Wolf Spirits, Inc.
Brand name: Prairie Wolf Distillery
Product recalled: Hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles
Reason of the recall: Packaged in containers resembling water bottles
FDA Recall date: June 22, 202... See More1
Recall details: Oklahoma City, Oklahoma, Prairie Wolf Spirits, Inc. is voluntarily recalling all lots of Prairie Wolf Distillery hand sanitizer packaged in 16.9 fluid ounce and 20 fluid ounce containers that resemble water bottles to the consumer level. The recall does not affect any other hand sanitizer products from Prairie Wolf Distillery. The product poses a risk of ingestion.

Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal.

Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute.

To date, Prairie Wolf Spirits has received no reports of adverse reactions 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 and is packaged in 16.9 ounce (UPC 6000331899) and 20 ounce plastic bottles (UPC 6000365984) that resemble water bottles. The product can be identified by the bottle’s labels pictured. The product was distributed to selected customers and consumers nationwide in the United States.

Prairie Wolf Spirits is notifying its customers by mail and is arranging for return or replacement of all recalled products. The product was sold from a temporary retail location located at 111 E. Oklahoma Avenue, Guthrie, Oklahoma 73044. Additionally, it was available on the manufacturer’s website, but there were limited sales. Prairie Wolf Spirits also donated the products from its Guthrie warehouse. Consumers that have the product which is being recalled should stop using it and return it to the Prairie Wolf Spirits distillery, 124 E. Oklahoma Avenue, Guthrie, Oklahoma, or discard it.

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.

Check the full recall details on fda.gov

Source: FDA
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June 22, 2021 3:01 PM

“Company name: Sanit Technologies LLC d/b/a Durisan
Brand name: Durisan
Product recalled: Hand sanitizer and hand sanitizing wipes
Reason of the recall: Microbial contamination
FDA Recall date: June 22, 2021
Recall details: Sanit Technologies LLC d/b/a Durisan, is providing an additional 5 label... See Moreillustrations and product sizes for customers that might not have been able to clearly identify containers of Non-Alcohol Hand Sanitizer products that were added to the voluntary recall initiated on March 24, 2021, and expanded by the April 10 and May 14, 2021 notices. To avoid any confusion, this press release provides copies of label illustrations for the recalled products.

Durisan Non Alcohol Antimicrobial Hand Sanitizer products became contaminated with a common municipal water supply borne bacteria, Burkholderia contaminans. Use of a hand sanitizer contaminated with Burkholderia contaminans, 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.

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 list of the lot numbers of the recalled products, which have a 24-month expiration, is included below.

Consumers and customers in possession of Durisan Non Alcohol Antimicrobial Hand Sanitizer products with these numbers in any form factor are encouraged to contact Durisan to return it.

The product is packaged in sizes ranging from 18mL credit card to 1-gallon containers. The lot number can be found in black print on the bottom of the package. Durisan Antimicrobial Solutions Hand Sanitizer Sizes With the Following Identification

- Volume mL: 18. Volume oz: 0.61. UPC: 8 52379 00614 1. NDC: 71120-112-01.
- Volume mL: 50. Volume oz: 1.69. UPC: 8 52379 00634 9. NDC: 71120-611-20.
- Volume mL: 118. Volume oz: 4. UPC: 8 52379 00612 9. NDC: 71120-112-10.
- Volume mL: 236. Volume oz: 8. UPC: 8 52379 00635 6. NDC: 71120-112-11.
- Volume mL: 250. Volume oz: 8.45. UPC: 8 52379 00611 0. NDC: 71120-611-03.
- Volume mL: 300. Volume oz: 10. UPC: 8 52379 00697 4. NDC: 71120-112-08.
- Volume mL: 550. Volume oz: 18.59. UPC: 8 52379 00620 2. NDC: 71120-112-06.
- Volume mL: 1000. Volume oz: 33.81. UPC: 8 52379 00610 3. NDC: 71120-112-05.
- Volume mL: 3785. Volume oz: 128. UPC: 8 52379 00621 9. NDC: 71120-611-05.
- Volume mL: 160 Ct Wipe. Volume oz: 5.63. UPC: 8 52379 00631 8. NDC: 71120-111-01.
- Volume mL: 80 Ct Wipe. Volume oz: 2.81. UPC: 8 52379 00632 5. NDC: 71120-111-03.
- Volume mL: 240 Ct Wipe. Volume oz: 8.44. UPC: 8 52379 00633 2. NDC: 71120-111-03.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Check the full recall details on fda.gov

Source: FDA
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June 24, 2021 3:29 PM

“Ordered a battery power chain saw June 5, 2921, got q wire with ring on each end. NOT WHAT WAS ADVERTISED OR ORDERED. Want my money back See Less
Reported By SafelyHQ.com User

Dreambones made in vietnam, Fort Worth, TX, USA

Symptoms: Diarrhea Vomiting
Fort Worth, TX, USA

June 24, 2021 3:09 PM

“Dreambones have been a favorite treat for my dogs. Normally purchased them from Walmart where they are made in China. Found some at a different store for less money but they are made in Vietnam. These made all 3 of my dogs ill..with vomiting and diarrhea. I pray they are OK. Vet could not get th... See Moreem in today. See Less
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June 24, 2021 10:09 AM

“All I received was a wire with rings. I want my money back this is a scam and I am turning it over to my attorney with all the order#s and receipt #. I ordered the battery powered chainsaws may and received a chain with rings. I want my money back or I'm turning it over to my attorney. I have a rec... See Moreeipt # and order #. This is total bulls*t. Who pays $28. for a piece of wire. The company was Amphitrite Technology See Less
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June 24, 2021 10:07 AM

“I received a ligature in the mail. My daughter and I were giggling about it, freaking about it, saying in their right mind would send this to me?!?! Today, I wanted to write to inquire about where in the world my CORDLESS CHAINSAW is, and I find all of these pictures OF MY LIGATURE!!!! WTH??
I’... See Morem on a very tight financial budget. That’s why I bought the dang thing. Screw me, I guess. See Less
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“Company name: Sanit Technologies LLC d/b/a Durisan
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Reason of the recall: Microbial contamination
FDA Recall date: June 22, 2021
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Consumers and customers in possession of Durisan Non Alcohol Antimicrobial Hand Sanitizer products with these numbers in any form factor are encouraged to contact Durisan to return it.

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- Volume mL: 550. Volume oz: 18.59. UPC: 8 52379 00620 2. NDC: 71120-112-06.
- Volume mL: 1000. Volume oz: 33.81. UPC: 8 52379 00610 3. NDC: 71120-112-05.
- Volume mL: 3785. Volume oz: 128. UPC: 8 52379 00621 9. NDC: 71120-611-05.
- Volume mL: 160 Ct Wipe. Volume oz: 5.63. UPC: 8 52379 00631 8. NDC: 71120-111-01.
- Volume mL: 80 Ct Wipe. Volume oz: 2.81. UPC: 8 52379 00632 5. NDC: 71120-111-03.
- Volume mL: 240 Ct Wipe. Volume oz: 8.44. UPC: 8 52379 00633 2. NDC: 71120-111-03.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Check the full recall details on fda.gov

Source: FDA
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