Cook Out

I was given the second dose of the vaccine and everything was very fast in the Benalcazar, there was practically no one and a side effect I only had a little pain in my arm for a day and a half | Symptoms: Soreness See Less

Embed Report Copy link

Company name: Jacobus Pharmaceutical Company Inc.
Brand name: Ruzurgi®
Product recalled: Ruzurgi® (amifampridine) 10 mg tablets
Reason of the recall: Exceeds Specification for Total Yeast and Mold Counts
FDA Recall date: September 13, 2021
Recall details: Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3... See More lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results.

Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections.

The product is used as a treatment for LEMS in patients ages 6 to less than 17 and is packaged in 100 count bottles (NDC: 49938-110-01). The affected Ruzurgi® (amifampridine) tablets lots include the following control numbers and expiration dates:
- Control Number 18038, Expiration 03/2023
- Control Number 18039, Expiration 03/2023
- Control Number 18079, Expiration 05/2023

The Control Number is located to the right of the bottle’s front panel below the D2 Barcode. Ruzurgi® (amifampridine) was distributed worldwide to specialty pharmacies and physicians.

Jacobus was informed of this issue by their Canadian partner that was conducting confirmatory full testing on Control Number 18038. Jacobus conducted an expanded investigation which identified Control Numbers 18039 and 18079.

- Control Number 18038 was distributed between 05/25/2021 – 08/26/2021 (Canada only)
- Control Number 18039 was distributed between 06/01/2021 – 08/10/2021
- Control Number 18079 was distributed between 08/10/2021 – 08/30/2021

Jacobus Pharmaceutical Company Inc is notifying its distributors and customers via regular mail and electronic mail and is arranging for the return of all recalled products.

Consumers that have Ruzurgi® (amifampridine) which is being recalled should stop using and return this product. Consumers with questions regarding this recall can contact Jacobus Pharmaceutical Company Inc. by phone at (609)799-8221 ext. 2120, Monday thru Friday from 9:00 AM to 5:00 PM Eastern Standard Time. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration and other health authorities.

Check the full recall details on fda.gov

Source: FDA See Less

Embed Report Copy link

I ordered the battery powered chain saw on May 9th and still have not received it. I would like my money back. Hahdiy
Not sure being it was so long ago See Less

Embed Report Copy link

Company name: Pfizer
Brand name: CHANTIX
Product recalled: Varenicline tablets
Reason of the recall: N-nitroso-varenicline above acceptable daily intake level
FDA Recall date: September 16, 2021
Recall details: Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level... See More due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure. Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. Check the link below for the full list of the recalled products.

The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Chantix is a treatment to help patients quit smoking and is intended for short-term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke.

Smoking is also associated with many other cancers, as well as with cardiovascular disease and lung disease. CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their healthcare provider about alternative treatment options.

To date, Pfizer has not received reports of adverse events assessed to be related to this recall. The NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets are indicated in Appendix A. Photos of the products can be found in Appendix B.

The products were distributed nationwide to Wholesalers and Distributors in the United States, US Virgin Islands, and Puerto Rico from May 2019 to September 2021. Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified their direct consignees by letter to arrange for return of any recalled product.

Wholesalers and Distributors with an existing inventory of Chantix tablets, should stop use and distribution and quarantine the product immediately. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately. Additionally, if you are aware of any patients to whom you dispensed the products and who still may have the product in their possession, please ask them to return the product.

As communicated by FDA, there is no immediate risk to patients taking Chantix.iv Patients who are taking this product should consult with their health care provider to determine if alternative treatments are available.

Check the full recall details on fda.gov

Source: FDA See Less

Embed Report Copy link

I saw an ad on the internet for a mini chainsaw called rosespros.
I paid $25.99 for it in May.
They took my money but I've never recieved the saw.

I'm so tired of being scammed by these crooked companies that float around on the internet and... See More basically steal from people. I ordered from an ad that popped up when I was playing a game See Less

Embed Report Copy link

The FSAI announced the recall of Aptonia sports food products by Decathlon due to the presence of the unauthorized pesticide ethylene oxide. Ethylene oxide is a pesticide that is not permitted for use in foods sold in the EU but is approved for use by other countries... See More outside the EU.

The recalled products are:
- Aptonia Vitamins and Minerals 30 tablets Orange flavour
- Aptonia salts caps 100 capsules
- Aptonia Electrolytes tablets Ecosize lemon flavour 2x20 tablets
- Aptonia Electrolytes tablets rasperry flavour 2x20 tablets
- Aptonia Electrolytes tablets lemon flavour 2x20 tablets

Although the consumption of the contaminated product does not pose an acute risk to health, there is an increased risk if there is continued consumption of contaminated food over a long period of time. Therefore, exposure to this substance needs to be minimized.

In case you are experiencing food poisoning symptoms, it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance.

For more recall details check on FSAI website: fsai.ie

Source: FSAI See Less

Embed Report Copy link

Bought a bag of heartland farms dog food from our local dollar store on 7-26-21, a week later we noticed that all 3 of our dogs had bloody stool, not long after that our youngest boxer started vomiting up blood. Called our local vet explained what was... See More going on and she said to stop feeding them for 24 hours and give them pepto bismol and switch them back to pedigree immediately. All the dogs are fine now as far as I can tell. What led me to voice my concern is a gentleman down the road lost 6 puppies two weeks after buying a bag of heartland food. I am in no way seeking anything. But there is definitely something wrong with the food. Thank you. | Symptoms: Vomiting, Bloody Stool See Less

Embed Report Copy link

Company name: Azurity Pharmaceuticals, Inc.
Brand name: Azurity
Product recalled: Firvanq
Reason of the recall: Product kit may contain incorrect diluent.
FDA Recall date: September 08, 2021
Recall details: Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution),... See More Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle. To date, Azurity has not received any reports of adverse events related to this recall.

Risk Statement: Vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label. There is reasonable probability that the administration of inappropriate doses of oral vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death. Especially, the elderly and immunocompromised patients are vulnerable to the complications of C. difficile infection.

Firvanq® is indicated for use in adults and pediatric patients less than 18 years of age for the treatment of: Clostridium difficile-associated diarrhea and Enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).

The recalled product is packaged as a kit consisting of a bottle with Vancomycin Hydrochloride, USP powder, a bottle of Grape-Flavored diluent, and Full Prescribing Information. The product NDC is 65628-206-05 and the UPC code is 3 65628 206005 1. A total of 2,751 kits of the affected Firvanq®, lot number 21035, with an expiration date of 2022-07-31 were distributed. The product can be identified by its brand name Firvanq®.

This product was distributed nationwide through wholesale distributors. Azurity is notifying its distributors and customers by direct notifications to distributors and via this press release. Azurity is arranging for return and replacement of only recalled products. Consumers, distributors, and retailers that are in possession of Firvanq® from the affected lot should immediately stop using it and return it to the place of purchase. Distributors are asked to place any affected product under quarantine and return it promptly to Azurity.

Check the full recall details on fda.gov

Source: FDA See Less

Embed Report Copy link

Company name: ICU Medical, Inc.
Brand name: Hospira
Product recalled: Aminosyn II, 15%, An Amino Acid Injection, Sulfite
Reason of the recall: Presence of visible particulate matter
FDA Recall date: September 07, 2021
Recall details: ICU Medical, Inc. is voluntarily recalling one lot (2,112 units) of Aminosyn... See More II, 15%, An Amino Acid Injection, Sulfite Free intravenous (IV) solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other particles. 

ICU Medical became aware of this issue while inspecting retain samples as part of routine process. Administration of a drug product that contains particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. 

To date, ICU Medical, Inc. has not received reports of adverse events or illnesses related to this recall. Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. 

Aminosyn II can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of nutritional support can help to preserve protein and reduce the breakdown of organic or inorganic materials, such as proteins, sugars, fatty acids, etc. in stress conditions where oral intake is inadequate. Aminosyn II is also indicated for central vein infusion to prevent or reverse excreting more nitrogen than is being taken in in patients where the intestinal tract, by the oral, surgical opening into the stomach for the introduction of food or surgical procedure for a feeding tube routes cannot or should not be used and gastrointestinal absorption of protein is impaired. 

Product was distributed nationwide both by ICU Medical direct to customers and through medical distributors. The product is for human use only. ICU Medical acquired this product from Hospira, a Pfizer company; therefore, the affected product contains a Hospira NDC number and a Hospira label. The affected product lot, manufactured in the U.S. by ICU Medical in November 2020, is listed below:  

- Aminosyn® II 15% An Amino Acid Injection, Sulfite-Free. NDC: 0409-7171-17. Catalog Number: 07171-17. Lot Number: 4989094. Expiration Date: 01-Apr-2022. Configuration: Pharmacy Bulk. Package 2-liter. Flexible. Container. Manufacture Date: November 2020. Distribution Dates: January 2021 – March 2021.

ICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products.

Hospitals/distributors that have a product that is being recalled should stop use/further distribution and return to the place of purchase.

Customers with questions regarding this recall can call ICU Medical at 1-844-654-7780 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.

Check the full recall details on fda.gov

Source: FDA See Less

Embed Report Copy link

Some individuals are fearing maybe the vaccines contain virus

Some people are not willing to be vaccinated against the virus which sometimes may lead to the rapid spread of the virus See Less

Embed Report Copy link