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Natural Organics, Inc., is voluntarily recalling four lots of NaturesPlus Keto Living Sugar Control Capsules 90 count, because it was found to contain gluten. People who have allergies to wheat or gluten run the risk of serious or life-threatening allergic reactions if they consume these products. There... See More have been no reported incidents of illness or adverse reactions in connection with these products to date.

Individuals with Gluten intolerance may experience minor to severe reactions after consuming this product. This could include upset stomach, diarrhea, fatigue, skin reactions and more. It was discovered during routine testing that the product contains gluten. It was subsequently discovered that a raw material that is normally gluten free tested positive for gluten.

Gluten is a general name for the proteins found in wheat (wheatberries, durum, emmer, semolina, spelt, farina, farro, graham, KAMUT® khorasan wheat and einkorn), rye, barley, and triticale – a cross between wheat and rye.

The listed products were distributed nationwide to consumers, retail stores and to the following foreign countries: Kenya, Spain, Trinidad, United Arab Emirates, and the United Kingdom. The capsules are packaged in white jars and black caps; with labels having orange, white and black print bearing the product codes, lot numbers and “Best By” or “BBE” (Best Before End) dates are printed on the bottom of the bottle.

The lots affected are:

- NATURES PLUS KETO LIVING SUGAR CONTROL CAPSULES, 90 CAPSULES, Product No. 82004, UPC Code 097467820043, Lots 1362073, Best By 10/2025 and 1365200, Best By 10/2025
- NATURES PLUS KETO LIVING SUGAR CONTROL CAPSULES, 90 CAPSULES, Product No. Ue82004, UPC Code 097467820043, Lots 1361754, BBE 10/2025 and 1364325, BBE 10/2025

Consumers who may have purchased affected lots of NaturesPlus Keto Living Sugar Control Capsules are advised to return them to the place of purchase. No other Natural Organics, Inc. products are affected by this recall. Natural Organics, Inc. has removed all affected products within existing inventory.

This voluntary recall is announced in accord with FDA guidelines. We are initiating recall notices to our accounts and consumers who received inventory of the recalled products with instructions for returning the recalled products and for notifying their customers of the recall. Consumers with questions may contact the company Monday – Friday, from 8:00 am to 4:30pm EDT.

Company name: NATURAL ORGANICS, INC
Brand name: NaturesPlus
Product recalled: Keto Living Sugar Control Capsules
Reason of the recall: Undeclared Gluten
FDA Recall date: May 06, 2022

Source: fda.gov
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Royal Philips (NYSE: PHG, AEX: PHIA), today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm. Philips Respironics... See More has identified that there is a possibility that affected ventilator units may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown), and the patient may no longer receive respiratory assistance.

Philips Respironics projects an average of less than one silent shutdown among one million uses per year. Philips Respironics is advising customers that they must implement one or more of the following actions to mitigate the rare possibility of the hazard caused by the 35V electric circuit issue:

- Implement an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus, or V680; and/or
- Connect the V60/V60 Plus or V680 to a nurse call/remote alarm system, as documented in the instructions for use; upon request, Philips Respironics can provide technical assistance to implement this nurse call/remote alarm capability; and/or
- Monitor the patient with pulse oximetry or other physiological monitoring appropriate to the institution’s capabilities and patient needs.

Additionally:
- An alternative means of ventilation should be available whenever the V60/V60 Plus or V680 ventilator is in use. If a fault is detected in the ventilator, disconnect the patient from it and immediately start ventilation with such an alternative device. The ventilator must be removed from clinical use and serviced by authorized service personnel.

If these mitigations are not available, Philips Respironics recommends each institution deliberately make a decision that balances the risks and benefits of continued use of the V60/V60 Plus and V680 against the risks and benefits of ceasing use and/or substituting other ventilators. Such decision-making should consider the institution’s capabilities and patient needs.

Philips Respironics is committed to addressing the issue and will provide regular updates to customers on the development of its plan to address the issue, with the first update to be provided before June 30, 2022. The V60/V60 Plus is not a life support ventilator. It is an assist ventilator and is intended to augment patient breathing. The V680 ventilator provides invasive and non-invasive respiratory support. The V60/V60 Plus and V680 ventilators are not authorized for use in a home or non-institutional setting.

Company name: Philips Respironics
Brand name: Philips Respironics
Product recalled: V60/V60 Plus, and V680
Reason of the recall: A potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm
FDA Recall date: May 02, 2022

Source: fda.gov
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St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli.

Burkholderia gladioli is an opportunistic pathogen most commonly affecting patients... See More with respiratory disease. Patients with compromised immune systems such as those with Cystic Fibrosis are at higher risk. Burkholderia gladioli also can cause complications after transplants. Exposure to contaminated product could lead to adverse events, which could be severe for at-risk individuals.

Fagron has received three complaints regarding an undesirable smell associated with the product. To date, Fagron has not received any reports of adverse events related to the product being recalled. Fagron sells this product for the extemporaneous compounding of prescriptions for oral dosing. The affected lots with expiration dates are listed below.

Affected products:
Lot: A67185
Item number: 805359
Size: 500 mL
NDC number: 51552-1123-5
Expiration date: 08/31/2024

Lot: A67186
Item number: 802496
Size: 4 L
NDC number:51551-1123-9
Expiration date: 08/31/2024

Fagron has already notified its distributors and customers by phone, e-mail, and/or letter and is arranging for return of all recalled products. Hospitals, pharmacies, and distributors that possess affected product should quarantine this material and await further instructions from Fagron or Fagron’s recall coordinator. Please immediately discontinue use or distribution of the recalled product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Fagron Inc.
Brand name: Fagron
Product recalled: SyrSpend SF 500mL and 4L
Reason of the recall: Potential contamination with Burkholderia gladioli
FDA Recall date: May 02, 2022

Source: fda.gov
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Boil Water Alerts for Businesses
Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Nitrosamines are common in water and foods, including... See More 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.i Accupril is indicated for the treatment of hypertension, to lower blood pressure. 

Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. Accupril® (Quinapril HCl Tablets), 10 mgAccupril® (Quinapril HCl Tablets), 20 mgAccupril® (Quinapril HCl Tablets), 40 mg.

NDC: 0071-0530-23
Lot Number: DR9639
Expiration Date: 2023 MAR 31
Strength: 10 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DX8682
Expiration Date: 2023 MAR 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0532-23
Lot Number: DG1188
Expiration Date: 2022 MAY 31
Strength: 20 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: DX6031
Expiration Date: 2023 MAR 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

NDC: 0071-0535-23
Lot Number: CK6260
Expiration Date: 2022 MAY 31
Strength: 40 mg
Configuration/ Count: 1 x 90 count bottle

Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, 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.

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 against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product.

Company name: Pfizer
Brand name: Pfizer
Product recalled: Accupril (Quinapril HCl) tablets 10mg, 20mg, 40 mg
Reason of the recall: Due to N-Nitroso-Quinapril Content
FDA Recall date: April 22, 2022

Source: fda.gov
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Alpine Fresh, Inc. of Doral, Florida is voluntarily recalling its 1 pound packages of "Hippie Organics" French Beans from lot# 313-626, because they have the potential to be contaminated with Listeria monocytogenes. The recalled "Hippie Organics 1lbs French Beans" were distributed in Whole Foods (CT, FL, GA,... See More IL, MD) , Aldi (FL) and LIDL (DE, GA, MD, NJ, NY, NC, PA, SC, VA) retail stores.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The product comes in a 1 pound, clear plastic package marked with lot # 313-626 on the back on a small, white label. No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after routine testing by the company revealed the presence of Listeria monocytogenes in 1 pound packages of "Hippie Organics French Beans  From lot # 313-626." The problem has been found to be isolated to the identified lot and the company has taken corrective actions to prevent a recurrence. Consumers who have purchased 1 pound packages of "Hippie Organics French Beans from lot #313-626" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-866-827-3362.

Company name: Alpine Fresh, Inc.
Brand name: Hippie Organics
Product recalled: French Beans
Reason of the recall: Listeria monocytogenes contamination
FDA Recall date: April 21, 2022

Source: fda.gov
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Babyganics is voluntarily recalling two lots of 20-ounce bottles of babyganics® 20oz chamomile verbena bubble bath, due to the presence of the bacterium Pluralibacter gergoviae. The products were sold in the last two months only at select retailers in the U.S.

During internal testing related to product... See More shelf life across the Babyganics bubble bath line, it was discovered that two specific lot numbers of this product contained the bacterium. While infants may be more susceptible than adults, Pluralibacter gergoviae does not usually cause healthy individuals to become sick. However, it may pose a risk of infection to those who are immunocompromised or have broken or irritated skin, such as diaper rash.

The only products affected are babyganics® 20oz chamomile verbena bubble bath UPC 8 13277 01375 4 with lot codes Y314 and Y315 found at the bottom of the packaging and contained in a white plastic bottle with a green plastic lid.

The testing confirmed that no other Babyganics products contained this bacterium. Babyganics takes pride in its commitment to vigorous consumer safety standards and providing peace of mind for parents, which is why the decision was made to voluntarily recover these bottles from retailers and to proactively reach out to consumers. Consumers with the affected product will be provided with a full refund after submitting their product and contact information at the company website. Consumers who have come into contact with the affected product and aren’t feeling well should contact their doctor.

Company name: Babyganics
Brand name: Babyganics
Product recalled: Chamomile verbena bubble bath
Reason of the recall: Presence of the bacterium Pluralibacter gergoviae, a bacterium
FDA Recall date: April 20, 2022

Source: fda.gov
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World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling case lot #38706503 of Organic Zucchini, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with... See More weakened immune systems. No illnesses have been reported to date. Organic Marketside Zucchini were distributed through select Walmart retail stores in Arizona, Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nebraska, North Dakota, Oklahoma, South Dakota, Texas, and Wisconsin.

Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Recalled Organic Marketside Zucchini can be identified by the following descriptions:

Organic Marketside. Packaging: Clear Overwrap Tray. Pack/Weight: 2ct / Net Wt. 6oz (170g). UPC Code: 6-81131-22105-4.
Case Lot Number: 38706503.

This recall was initiated because a single lot of imported organic zucchini tested positive for salmonella as a result of a routine FDA sampling.

Consumers who have purchased Organic Marketside Zucchini are urged to destroy and dispose of recalled product.

Company name: World Variety Produce, Inc.
Brand name: Organic Marketside
Product recalled: Organic Zucchini
Reason of the recall: Salmonella
FDA Recall date: April 19, 2022

Source: fda.gov
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The Salsa Texan of Flower Mound, Texas is voluntarily recalling all regular and burrito sized packages of tortillas labeled as Coconut Flour Tortillas and Blended Flour Tortillas because they may contain undeclared wheat and milk. The recalled tortillas were distributed nationwide through the mail, following orders made... See More via the social media platforms, Facebook and Instagram. The recalled tortillas were also sold at various Farmers Markets in Texas. Farmers Market locations include: Canton First Monday, Lucas, Texas Community Market, St. Michael’s, Red Tent Market at Willowbend, Luscombe Farm, Rockwall, Garland, and Heath.

The recalled products come in a clear plastic package marked with The Salsa Texan on the top or may be sold unlabeled. There are no best by dates or lot codes applied to the recalled product, therefore consumers should consider all Salsa Texan flour tortillas to be included in this recall.

Consumers who have purchased The Salsa Texan tortillas are urged to destroy them if they have an allergy or sensitivity to wheat or milk. Customers with Celiac disease and gluten sensitivity have confirmed illness following consumption of the recalled tortillas.

The voluntary recall was initiated after it was discovered that the tortillas were distributed in packaging that did not reveal the presence of wheat or milk. Distribution of the tortillas have been suspended until the FDA and the company are certain that the problem has been corrected.

Company name: The Salsa Texan
Brand name: The Salsa Texan
Product recalled: Tortillas
Reason of the recall: Undeclared wheat and milk
FDA Recall date: April 15, 2022

Source: fda.gov
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Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine- yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This product is not the branded Semglee vial but the unbranded Insulin... See More Glargine- yfgn vial. This batch is being recalled due to the potential for the label to be missing on some vials.

The product information, batch number and expiry date information are present on the carton. This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between December 9, 2021, and March 4, 2022. The recalled batch is as follows:

NDC # 49502-393-80
Name and Strength: Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100)
Size: 10 mL vial
Batch# BF21002800
Expiry: Aug 2023

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

This recall does not pertain to the branded interchangeable biosimilar, Semglee® (insulin glargine-yfgn) injection but to the unbranded interchangeable biosimilar Insulin Glargine-yfgn vial.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Mylan Pharmaceuticals, Inc. a Viatris Company
Brand name: Mylan
Product recalled: Insulin Glargine (Insulin glargine-yfgn) Injection
Reason of the recall: Label may be missing on some vials
FDA Recall date: April 12, 2022

Source: fda.gov
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Unilever United States is voluntarily recalling two Suave 24-Hour Protection Aerosol Antiperspirants to the consumer level. An internal review showed slightly elevated levels of benzene in some product samples. While benzene is not an ingredient in any of the recalled products, the review showed that unexpected levels... See More of benzene came from the propellant that sprays the product out of the can.
Benzene is classified as a human carcinogen. The affected products were in limited distribution at U.S. retail stores and online.

Unilever is recalling all lots of the products below with an expiration date through September 2023. No other Unilever or Suave products are in the scope of this recall. 

UPC: 079400751508; 079400784902
Description: Suave 24-Hour Protection Aerosol Antiperspirant Powder
Size: 4 oz; 6 oz

UPC: 079400785503
Description: Suave 24-Hour Protection Aerosol Antiperspirant Fresh
Size: 6 oz

Exposure to benzene can occur by inhalation, orally, and through the skin; it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources. Based on an independent health hazard evaluation, daily exposure to benzene in the recalled products at the levels detected in testing would not be expected to cause adverse health consequences.

The Suave 24-Hour Protection Aerosol Antiperspirant product line was discontinued in October 2021 for business reasons. Retailers have been notified to remove recalled products from shelves. Consumers should stop using and appropriately discard the affected Suave 24-Hour Protection Aerosol Antiperspirant products.

Company name: Unilever
Brand name: Suave
Product recalled: Aerosol Antiperspirants
Reason of the recall: Elevated levels of benzene
FDA Recall date: March 30, 2022

Source: fda.gov
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