Steak 'n Shake

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

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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

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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

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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

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Company name: Teligent Pharma, Inc.
Brand name: Teligent
Product recalled: Lidocaine HCl Topical Solution 4%
Reason of the recall: Super potency
FDA Recall date: August 30, 2021
Recall details: Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl Topical Solution 4%, 50ml in a screw... See More cap glass bottle to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.

Risk Statement: Use of the super potent product would result in a higher than intended lidocaine dose above that intended.  An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient.  Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly.

If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered.

To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall. The product is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract and is packaged in a 50ml glass bottle with a screw cap with the identification NDC# 52565-009-50.  The affected Lidocaine HCl Topical Solution 4% lot number and expiration date are:  Lot # 14218, Exp. 09/2022.  The product can be identified by the following labeling:  Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL).  

Product was distributed at the wholesale and retail distribution levels in the US and Canada. Teligent Pharma, Inc. is notifying its distributors via Fed-Ex and is arranging for return of all recalled products. Distributors, consumers, and patients that have Lidocaine HCl Topical Solution 4% which is being recalled should return product to their place of purchase.

Consumers with questions regarding this recall can contact Teligent Pharma, Inc. by phone at 1-856-697-1441 press * to reach the medical information call center Monday through Friday, 8am – 5pm. 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.

Check the full recall details on fda.gov

Source: FDA See Less

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The FSAI announced the recall of unauthorized novel CBD food supplements due to the presence of unsafe levels of delta‐9‐tetrahydrocannabinol (THC) based on the European Food Safety Authority (EFSA) acute reference dose.

The recalled products are:
- Jacob Hooy, 2.75%CBD+, 10 ml, Batch number: 060977-0302, Best before... See More date: Feb-2022.
- Greenway, CBD Hemp Oil, 10 ml, Batch number: CB60001, Best before date: 10/12/2022.
- The Hemp Company, CBD Oil Original, 10 ml, Batch number: 10-10-139, Best before date: 04/2022.

FSAI requested to distributors withdraw the product from the market, and Retailers remove the products from sale. Consumers should not purchase or consume any of the implicated batches of the unauthorized novel CBD food supplements.

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

Source: FSAI See Less

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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

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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

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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

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PetSmart, in cooperation with the Consumer Product Safety Commission (CPSC), announced a voluntary recall of more than 100,000 of the Top Paw® Double Diner Dog Bowl after learning of a potential risk of laceration if the gasket on the bottom of the product comes off, leaving an... See More unfinished edge. No other products are affected by this recall.

According to CPSC, PetSmart has received three reports of consumers receiving cuts and scratches after handling the bowls with the unfinished edge.

- Top Paw® Double Diner Dog Bowl. SKU: 5270098. UPC: 73725775404

The recalled product is described as a set of two elevated metal dog food bowls that sit in a metal base surrounded by a plastic gasket. The bowls were sold at the pet stores from October 2017 through June 2021.

The company advises consumers to immediately stop using the recalled product and to the nearest PetSmart for a full refund.

Source: petsmartcorporate.com See Less

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