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Recent Interesting Reports
Fort Myers, FL, USA
May 10, 2021 1:47 PM
“I ordered two of the Outdoor orange saws off of fb on March I have not received either one. Invoice #489-10127461
Transaction # 1ym4274N33939154. I really need them as they were gifts. One of them was my husband's birthday present at the end of March They were ordered early and they removed t... he money from my account March 6, 2021. They still show them on FB. They also sent that email to me. After checking with others, information is not correct. Never delivered. ”
Imperia Elita Vitaccino Coffee dietary supplement - recalled due to undeclared Sibutramine and Fluoxetine, USA
May 11, 2021 3:01 PM
“Company name: Dash Xclusive
Brand name: Imperia Elita
Product recalled: Vitaccino Coffee weight loss and anxiety dietary supplement
Reason of the recall: Undeclared Sibutramine and Fluoxetine
FDA Recall date: May 11, 2021
Recall details: Glendale, California, Dash Xclusive is voluntarily recal... ling 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 Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues, including stroke, heart failure and serious health risk especially to those with underlying heart related disease.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, 610 S. Verdugo Road, Apt 31, Glendale, California 91205. Consumers with questions regarding this recall can contact Dash Xclusive by e-mail at email@example.com on Mondays to Thursdays from 11am to 4pm Pacific Time zone.
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. 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.
Check the full recall details on fda.gov
Source: FDA ”
Tenacore LLC 2001 Tenacore Replacement CareFusion Alaris 8100 bezels - recalled due to Potentially weakened elastic, USA
April 19, 2021 9:01 PM
“Company name: Tenacore LLC
Brand name: Tenacore LLC
Product recalled: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Reason of the recall: Potentially weakened elastic
FDA Recall date: April 19, 2021
Recall details: Company Announcement On February 24th, 2021, Tenacore LLC initiated a... nationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion. There is a related recall initiated by Becton Dickinson (BD). Information regarding that recall can be found using the following link: Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion | FDA Consumers who have: Tenacore bezel parts (part number TIPA-8100-4410) with timestamp 5 and/or timestamp 6 should stop the distribution and use of these and return them to Tenacore LLC.
Alaris 8100 units that were serviced by Tenacore, or purchased from Tenacore between July 2020 and Feb 2020, should be inspected per the instructions described below to ensure that your device is not impacted. If it is, please return your device to Tenacore LLC.
Recalled bezels were manufactured from May 2020 to June 2020 and distributed from July 2020 through Feb 2021. The following products have been recalled:
Check the full recall details on fda.gov
Source: FDA ”
Kibbles and bits bistro, Walmart Supercenter, South Oates Street, Dothan, AL, USA, Walmart Supercenter, South Oates Street, Dothan, AL, USA
Walmart Supercenter, South Oates Street, Dothan, AL, USA
April 18, 2021 10:04 AM
“I have 2 sick, A week and a half ago Née bag of Kibbles and bits bistro and the Melody Just started about a week and a half ago now I have two dogs sick one with an IV in the hospital ”
Doctor Visit: Yes
Redwood City, CA, USA
April 21, 2021 12:38 PM
“Blackcass.com is a total scam. My wife bought me what she thought was a mini electric chain saw. The site showed a sthil chain saw for $29.99 instead of $59.99. Not knowing the prices on tools she thought to surprise me. The next day I found her order in our computer and immediately contacted them a... nd tried to cancel it. They said it was too late as the order had already been processed. 10 weeks later we got a hand rose clipper instead. My wife had paid $37.99 for a clipper I got at Ace hardware before for $9.99 ”
Symptoms: Fatigue Lightheaded Muscle Pain Soreness
Walgreens, Ohio 43, Streetsboro, OH, USA
April 28, 2021 5:52 PM
“Got the first dose of the Pfizer vaccine yesterday at Walgreens. Process was very smooth, no allergic reactions. Had some initial wooziness and lightheadedness 5 minutes after receiving the vaccine but may have just been anxiety.
Symptoms after 27 hours: sore arm, joint and muscle pain, fatigue.... Feeling warm/flushed but no fever. ”
Alameda, CA, USA
May 4, 2021 2:10 PM
“I bought a battery powered woodcutting saw from Kenyak. I recieved a chain with two rings. How can we stop these people. I bought this a couple months ago and today the ad is still running on USA today. Please help. Please stop these people. The add is still on USA today ”
Symptoms: Other Headache
Lauderhill, Florida, USA
April 25, 2021 12:35 PM
“I am having side effects. the left side of my mouth moves by it self, and air comes out. it did it back to back. my head and neck was hurting. also at times my beath stops for a brife second. these things never happened before. should i go to the hospital ”
May 12, 2021 8:00 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 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 ”
Fort Smith, AR, USA
April 30, 2021 3:56 PM
“The same still saw scam as the other people on here. Same ad. It states $19.99 for that day and I ordered it. I also got the little manual wire saw. It said saw and accessories. It really hurts people on a fixed income. I hope they are proud of themselve ”