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Product: Evolve

Updated: July 30, 2021 12:03 AM
Company name: Sunshine Mills, Inc.
Brand name: Triumph, Evolve, Nature Farms, Elm and others
Product recalled: Dog Food
Reason of the recall: Elevated Levels of Aflatoxin
FDA Recall date: July 29, 2021
Recall details: Sunshine Mills, Inc. is issuing a voluntary recall of certain products due to... See More potentially elevated levels of Aflatoxin above the acceptable limit. Aflatoxin is a naturally occurring by-product from the growth of Aspergillus flavus and can be harmful to pets if consumed in significant quantities. No illnesses have been reported in association with these products to date, and no other Sunshine Mills, Inc. pet food products are affected by this announcement. Products affected by this announcement:

- Triumph® Wild Spirit Craft Dog Food Deboned Chicken & Brown Rice Recipe (3.5 Lbs.). Lot Codes: Best If Used By 11 Feb 2022 Lot: Td2 11/Feb/2021. UPC Code: 073657 008736.
- Triumph® Wild Spirit Craft Dog Food Deboned Chicken & Brown Rice Recipe (30 Lbs.). Lot Codes: Best If Used By 11 Feb 2022 Lot: Ta2 11/Feb/2021. UPC Code: 073657 008750.
- Evolve® Classic Super Premium Food For Dogs Deboned Chicken & Brown (15 Lbs.). Lot Codes: Best If Used By 11 Feb 2022 Lot: Ta1 11/Feb/2021. UPC Code: 073657 380320.
- Wild Harvest® Premium Dog Food Chicken & Brown Rice Recipe (14 Lbs.). Lot Codes: Best If Used By 11 Feb 2022 Lot: Ta2 11/Feb/2021. UPC Code: 711535 509523.
- Nurture Farms® Natural Dog Food Deboned Chicken & Brown Rice Recipe (15 Lbs.). Lot Codes: Best If Used By 11 Feb 2022 Lot: Ta2 11/Feb/2021. UPC Code: 070155 113597.
- Evolve® Classic Super Premium Food For Dogs Deboned Chicken & Brown (30 Lbs.). Lot Codes: Best If Used By 11 Feb 2022 Lot: Ta2 11/Feb/2021. UPC Code: 073657 380313.
- Heart To Tail Pure Being® Natural Dog Food Deboned Chicken & Brown Rice Recipe (5 Lbs.). Lot Codes: Best If Used By 11 Feb 2022 Lot: Td2 11/Feb/2021. UPC Code: 4099100129441.
- Elm Pet Foods Naturals Chicken & Rice Recipe Dog Food (40 Lbs.). Lot Codes: Best If Used By 11 Feb 2022 Lot: Ta1 11/Feb/2021. UPC Code: 070155 225221.

The affected products were distributed in retail stores nationally. Retailers who received the recalled lots have been contacted and asked to pull these lots from their inventory and shelves. There are no other Triumph®, Evolve®, Wild Harvest®, Nurture Farms®, Pure Being®, or Elm products or other lot codes of these products affected by this recall.

While no adverse health effects related to these products have been reported, Sunshine Mills, Inc. has chosen to issue a voluntary recall of the above-referenced products as a precautionary measure in furtherance of its commitment to the safety and quality of its products. Pets that have consumed any of the above recalled products and exhibit symptoms of illness including sluggishness or lethargy combined with a reluctance to eat, vomiting, yellowish tint to the eyes or gums, or diarrhea should be seen by a veterinarian.

Consumers who have purchased the recalled products should discontinue use of the product and may return the unused portion to the place of purchase for a full refund.

Check the full recall details on fda.gov

Source: FDA
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Company name: CME America
Brand name: CMEAmerica BodyGuard
Product recalled: Infusion pumps and infusion sets
Reason of the recall: pumps may not deliver fluid at the accuracy specified in the instructions for use and infusion sets may under-deliver fluids
FDA Recall date: April 29, 2020
Recall details:... See More CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1474-2020) and the other related to one of the device's infusion sets (FDA Recall Number: Z-1442-2020). Both previously announced recalls have now been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means the FDA believes that there is a reasonable probability that use of the recalled product(s) will cause serious adverse health consequences or death.

CME America previously notified customers affected by each recall and provided guidance on the potential impact to device performance when the affected products were used. Today, the company has issued an updated customer letter with additional guidance and to inform customers of the decision to suspend distribution of the BodyGuard® infusion pump system and to remove all existing products from the U.S. market.

The following is a summary of each individual product recall details:

CMEAmerica BodyGuard® Infusion Pump Recall

Details On Jan. 6, 2020, the company initiated a voluntary recall to notify customers of certain scenarios where pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion). Results indicate that pumps may have a delivery inaccuracy of up to ~13%. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America has assessed the potential risks associated with the issues outlined in the initial voluntary recall and determined that the BodyGuard® infusion pump may continue to be used in certain situations in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter until the pumps have been removed from the market.

To ensure customers retain access to critical medical equipment, particularly as the COVID-19 pandemic continues to evolve in the United States, CME America will implement a phased market removal and will continue to support the following activities in order to help limit clinical disruption and maintain patient focus during the COVID-19 pandemic: Use of products in the field in accordance with the Operator's Manual and the additional mitigations outlined in the updated customer letter; Product service and repair activities at CME America and Authorized Service Depots; and Supply of infusion sets and accessories to support the infusion pumps remaining in the field.

The BodyGuard® infusion pump is designed to deliver fluids or medications into a patient's body in controlled amounts. The pump administers fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments. Typical applications for the BodyGuard® infusion pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affect approximately 28,400 devices, including all models of BodyGuard® infusion pumps listed below. These devices are primarily used in outpatient settings.
- BodyGuard 121
- BodyGuard 323
- BodyGuard 545*
- BodyGuard 575*
- BodyGuard 545 ColorVision
- BodyGuard 575 ColorVision
- CMExpress

*Note: These two pump models were inadvertently left out of the initial customer notification

CMEAmerica BodyGuard® Microset Infusion Set Recall

Details On Sept. 16, 2019, the company initiated a voluntary recall to notify customers that certain lots of BodyGuard® Microset infusion sets, when used with the BodyGuard® infusion pump, may under-deliver fluids up to 50% at the highest flow rates. At the time of the recall, CME America informed customers in the recall announcement to discard all remaining inventory of the infusion sets (Catalog #A120-003XYVA) and committed to reimbursing impacted customers. To date, no reports of patient injury has been received related to this previously announced voluntary recall. CME America immediately stopped shipments of the affected infusion sets. This FDA classification does not change the previous guidance provided in the company's September recall announcement to customers. Affected products include:

CMEAmerica BodyGuard® Microset, Catalog #A120-003XYVA.

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
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Recent Interesting Reports

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
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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
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Company name: Top Quality Dog Food
Brand name: Top Quality Dog Food.com
Product recalled: Beef HVM
Reason of the recall: Potential Salmonella & Listeria monocytogenes contamination
FDA Recall date: August 26, 2021
Recall details: Top Quality Dog Food of Hyattsville, MD is recalling “Beef HVM” 1-pound packages... See More due to the potential of Salmonella spp., Listeria monocytogenes. Salmonella, Listeria, can affect animals eating the product and there is risk to humans handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products. Healthy people infected with Salmonella should monitor themselves for the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever, and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, vulnerable or elderly people, and others with compromised immune systems. Healthy people may suffer short-term symptoms such as fever, headaches, stiffness, abdominal pain, and diarrhea. Listeria monocytogenes infections pose a serious threat to pregnant woman, as it can lead to miscarriages and stillbirths. Listeria monocytogenes infections are uncommon in pets, but they are possible. Symptoms may include mild to severe diarrhea; anorexia; fever; nervous, muscular, and respiratory signs; abortion; depression; shock; and death. Healthy people should monitor themselves and their pets for symptoms.

The recalled “Beef HVM” was distributed in DC, MD, VA, DE, PA, MA, CT, and SC and product was distributed through mail order and direct delivery from 7/27/21 to 8/2/21. The “Beef HVM” comes in a 1-pound package marked with lot #071521 on the bottom right corner of the label.

No illnesses have been reported to date in connection with the “Beef HVM” 1-pound packages in question.

The contamination was noted after a state surveillance sample revealed the presence of Salmonella, Listeria monocytogenes, in some 1-pound. packages of Beef HVM. The remaining “Beef HVM” batch in our possession has been quarantined and we have discontinued the distribution of this batch while FDA and our company continue their investigation as to the source of the contamination. 

We encourage all customers who received this product to dispose of any unused product immediately. If you find the “Beef HVM” 1-pound package that shows the lot number: 071521 in your possession, we urge you to return it to the place of purchase for a full refund.

Check the full recall details on fda.gov

Source: FDA
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A boiled water advisory surrounds our street while at the same time we experience very low water pressure especially on higher floors. See Less

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
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I ordered a wood cutter, chain saw, rechargeable on 3/18/21.  The linked showed up on Facebook.  I did not receive my chain saw.  Apparently the company, Amphitrite Technology Limited has been scamming people all year.  It wasn’t until I found your website that I realized I had... See More been sent this weird chain, hand cutter.  There are many pictures posted on your site of the same product.  I had no idea why this thing came to me.  I did not think it was a “replacement” or substitute for the little chain saw that was rechargeable.   

I can see there are several posts about the same problem. What can be done? Why has PayPal continued to allow the seller to sell? What can you do? What can I do, to stop others from the company”s fraud?

I purchased through PayPal; directly after this purchase my bank notified me that someone tried to buy a cell phone. What happens next? With so many reports of fraud, why hasn’t the seller been reported to officials? What can you do? What can I do on my part? I contacted PayPal. The company should be blocked from selling
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Scam Hahdi, CT, USA

2 weeks ago

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

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
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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
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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