CORE essential nutrients and Immune Boost Sublingual Vitamin D3 - recalled due to Unapproved new drug, USA

November 23, 2020 2:00 PM

United States

Company name: Fusion Health and Vitality LLC
Brand name: CORE, Immune Boost
Product recalled: CORE essential nutrients and Immune Boost Sublingual Vitamin D3
Reason of the recall: Unapproved new drug
FDA Recall date: November 23, 2020
Recall details: Fusion Health and Vitality LLCis voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that caused it to become and unapproved new drug under FDA labeling laws. Hordenine HCl is possibly unsafe when taken by mouth. Hordenine HCl might have similar stimulant effects and side effects such as rapid heart rate and high blood pressure.

Fusion Health and Vitality LLC has not received any reports of adverse events related to this recall.  Please review the attached photos for identification. We began shipping Core Essential Nutrients on 1/2/2020 and we began shipping Immune Boost Sublingual Vitamin D3 on 4/15/2020. Both products are packaged with labels which prominently display the product name.  CORE essential nutrients are found in a dark colored jar, in powdered format. 

This product was formulated to mix into a liquid before consumption. The Immune Boost sublingual was packaged in a 2 ounce bottle that came with a sublingual application dropper. Fusion Health and Vitality is notifying its customers by email and is arranging for return of all recalled products. Consumers that have product which is being recalled should stop using it and return it to Fusion Health and Vitality for destruction. Consumers with questions regarding this recall or how to return recalled product can contact Fusion Health and Vitality by calling 1-888-964-5327, 9am to 5pm, Monday Thru Friday, EST. 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.

Check the full recall details on fda.gov

Source: FDA

January 18, 2021 5:19 PM

“I just finished getting my second Pfizer Covid-19 vaccination 1 week ago, and the only side effect I had was a sore arm, from both of them. Many of my coworkers got fever, chills, headache, and vomiting. But not me. I had absolutely nothing. See Less”

January 18, 2021 5:13 PM

“My dog ate the dreambone grill masters chicken wing treat and within 12 hours he was getting sick. Took him to the vet in the morning and was having surgery that night. Not even 24 hours after eating it. The treat lodged itself in his small intestine causing a blockage. See Less”

January 18, 2021 5:08 PM

“It was done in the morning I waited in line for 1 hour . Took the vaccine in my arm . Waited 15 minutes then went home. Got home I felt little sick but nothing major. My arm was soar 3 days . No problems . Moderna vaccine was good I recommend this shot to everyone. See Less”

January 18, 2021 5:06 PM

“My first shot was last Wednesday (1/13). I only experienced some arm soreness that night and even more the next day. By Friday all was normal. I am awaiting dose two. I expect some side effects for 24 hours after dose 2, as my brother who is an IM doctor got feverish and achy with some nausea and w... See Moree react similarly to vaccines. He was fine after about 36 hours. I will take a day of symptoms over my life any day. I hope this helps somebody. See Less”

January 18, 2021 5:02 PM

“I received my first dose of the Moderna COVID 19 Vaccine in December 28, 2020. I received my Vaccine in the afterneen and about 8 hours later a began to have a slight sore arm. Like the pain you get from Flu or tetanus Vaccine. Lasted about a day and a half. That was all I had in the way of side ef... See Morefects. I also have never been prior Covid Positive. I will do a second report after I receive my second dose. See Less”

January 18, 2021 1:56 PM

“I ordered the hand held cutter and received something not related to my order. Take them DOWN NOW See Less”

January 17, 2021 12:00 PM

“An employee at Starbucks located on North H Street in Lompoc recently tested positive for Covid-19

Source: ksby.com See Less”

January 17, 2021 12:00 PM

“An employee at Howard County Library System HCLS located on Glenwood Branch in Cooksville recently tested positive for Covid-19

Source: patch.com See Less”

January 17, 2021 12:00 PM

“6 employee at New London City Public Works located on Union St in New London recently tested positive for Covid-19

Source: theday.com See Less”

January 17, 2021 12:00 PM

“81 staff members and 102 students at Cypress-Fairbanks Independent School District located in TX recently tested positive for Covid-19

Source: communityimpact.com See Less”

January 4, 2021 11:39 PM

“I ordered this saw on December 13th, on December 15th I recieved a confirmation notice the my purchase was on its way, today January 4th 2021 in the mail all I recieved was a chain. Is this a scam or what,and where is the rest of my purchased SAW????? See Less”

December 31, 2020 11:24 AM

“Responding to an add on facebook I ordered and paid for a battery powered chainsaw on Dec. 13. I then received a confirmation email. On Dec. 30 I received an envelope the size of a cigarette pack containing a manual chainsaw. Where are the fact checkers when you need them? See Less”

January 14, 2021 8:47 PM

“The owner refused to wipe down the countertop or the card swipe after me requesting him to do so after several people using it. I want everyone to refrain from going to this station since he does nothing to protect people during covid 19 See Less”

January 14, 2021 8:51 PM

“I am a teacher and am authorized to get the Moderna vaccine. I made an appointment in Ridgewood 2 days ago. Appoint was at 5:20 but didn't get my shot until 7:40. The lines are extremely long at night. But the nurse said they are empty in the morning. Once you get inside it is very fast, everyone is... See Morevery helpful and you can sign up for your second vaccine. They make you wait 15 mins to make sure you're ok before you leave. I have no side effects from the shot and feel fine. See Less”

January 1, 2021 8:08 AM

“Ordered Stihl pruner from Blackcass. 2020 Hot Selling GTA 26 Battery Powered Wood Cutter $29.99. Says style Outdoor Portable Carbon Steel Chain. I assumed this meant the chain was carbon steel. Ad goes on to list what's included. You can view their ads online. Received the chain only. When I contac... See Moreted company, they informed me I had only ordered the chain. Who buys just the chain? I am finding others who are experiencing the same issue. Disputing through PayPal also. Feel this is quite the scam. See Less”

January 8, 2021 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL
Reason of the recall: Presence of particulate matter
FDA Recall date: January 08, 2021
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Ketoro... See Morelac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine Injection should not exceed 5 days. Listed below is a table of the recalled lot distributed nationwide in the United States to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019.

Product Name/Product size: Ketorolac Tromethamine Injection, USP, 30mg / mL, 1 mL fill in a 2 mL amber vial
NDC Number: 63323-162-01
Product Code: 160201
Batch Number: 6121083
Expiration Date: 02/2021
First Ship Date: 03/28/2019
Last Ship Date: 09/03/2019

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing the affected lot, and to return the product to Fresenius Kabi.

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”

December 30, 2020 9:21 AM

“The FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products manufactured by Midwestern Pet Foods, Inc. that may contain potentially fatal levels of aflatoxin. As of December 30, 2020, 28 deaths and 8 illnesses in dogs that ate the recalled product have been r... See Moreeported. This is an ongoing investigation. Case counts and the scope of this recall may expand as new information becomes available.

Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets. Pets experiencing aflatoxin poisoning may have symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes or gums due to liver damage), and/or diarrhea. In severe cases, this toxicity can be fatal. In some cases, pets may suffer liver damage but not show any symptoms.

Pet owners should stop feeding their pets the recalled products listed below and consult their veterinarian, especially if the pet is showing signs of illness. The pet owner should remove the food and make sure no other animals have access to the recalled product. Sanitize pet food bowls, scoops, and storage containers using bleach, rinsing well afterwards with water, and drying thoroughly. There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning.

Midwest Pet Food, Inc. already recalled the following lots of Sportmix pet food products:
- Sportmix Energy Plus, 50 lb. bag. Lots: Exp 03/02/22/05/L2 | Exp 03/02/22/05/L3 | Exp 03/03/22/05/L2
- Sportmix Energy Plus, 44 lb. bag. Lot: Exp 03/02/22/05/L3
- Sportmix Premium High Energy, 50 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Premium High Energy, 44 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Original Cat, 31 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Original Cat, 15 lb. bag. Lots: Exp 03/03/22/05/L2 | Exp 03/03/22/05/L3

Check the full outbreak announcement on fda.gov

Source: FDA See Less”

January 5, 2021 9:18 AM

“On 12/6/20, I had ordered 2 chainsaws as Christmas gifts for $65.97, but only received 2 vinyl pouches containing the chains to the saws. I contacted the seller to find out when I could expect the delivery on the saws, along with any tracking info they could provide on the items. A few days later th... See Moreey contacted me by email saying for me to check my order details, what I had ordered was the chains, and if I wanted the saws they were $89.99 each. So since I paid through PayPal, I will be reporting the issue and trying to retrieve my monies back. See Less”

January 7, 2021 1:49 PM

“BlackCass. I ordered a hand-held saw and received only an extra chain. Can I get a refund? See Less”

December 27, 2020 3:02 PM

“False advertising misleading GTA 26 was ordered only received blades pictures of item was not item that I received See Less”