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United States

Updated: June 22, 2022 8:00 PM
BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BDTM Intraosseous Needle Set Kits, BDTM Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers. Certain lots within the expiration date of these intraosseous products may result in the following:... See More - Difficulty separating the stylet from the intraosseous needle, where increased force required to remove the stylet from the intraosseous needle results in inadvertent removal of the entire needle assembly during placement or inability to remove the stylet from an indwelling intraosseous needle, both resulting in functional loss of intraosseous access.

- Needle safety mechanism on the stylet not deploying post placement of the intraosseous needle and removal of the stylet from the needle.

- Metal discs intended to connect the needle assembly to the magnet in the powered driver sticking unexpectedly to the magnet, rendering the driver unable to be used.

These issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries.

Impacted products include:

- Needle Kit for Powered Driver 15mm x 15Ga. Catalog No.: D015151NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 15mm x 15Ga. Catalog No.: D015151MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 25mm x 15Ga. Catalog No.: D015251NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 25mm x 15Ga. Catalog No.: D015251MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 35mm x 15Ga. Catalog No.: D015351NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 35mm x 15Ga. Catalog No.: D015351MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 45mm x 15Ga. Catalog No.: D015451NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 45mm x 15Ga. Catalog No.: D015451MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Needle Kit for Powered Driver 55mm x 15Ga. Catalog No.: D015551NK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Manual Driver Needle Kit 55mm x 15Ga. Catalog No.: D015551MK. UDI: See the link below. Lot No.: See the link below. Expiration Date See the link below. Product Package Size: 1 device per package.
- Intraosseous Powered Driver (drill). Catalog No.: D001001. UDI: 801741163579. Lot No.: All. Expiration Date All. Product Package Size: 1 device per package.

Customers should immediately review their inventory for the catalog and lot numbers listed above. Affected needle kits should be destroyed in compliance with the health care institution’s process for disposal. The use of affected intraosseous powered drivers should be paused until a BD representative provides instruction that it is safe for use. There are no replacement products currently.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: BD
Brand name: BDTM
Product recalled: Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered Drivers
Reason of the recall: Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries
FDA Recall date: June 22, 2022

Source: fda.gov
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Vi-Jon, LLC is voluntarily recalling 1 (one) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacter liquefaciens. This lot of Magnesium Citrate Saline... See More Laxative Oral Solution Lemon Flavor was distributed Nationwide at CVS drug store locations.

Risk Statement: Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life threatening adverse health consequences. To date, Vi-Jon, LLC has not received any complaints related to this recall. The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in 1/2 to 6 hours.

The product is packaged in a 10 oz clear round plastic bottle. The affected CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor lot includes the following batch number: 0556808 and expiration date: 12/2023 on the shoulder of the bottle. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was sent to a 3rd Party Outside Lab for testing per CVS request as a first production sample for CVS.

Vi-Jon, LLC has already notified CVS by phone and email and is arranging for return of all recalled product. Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.

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

In case you experienced harm this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Vi-Jon, LLC
Brand name: CVS Health
Product recalled: Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
Reason of the recall: Microbial contamination with Gluconacetobacter liquefaciens
FDA Recall date: June 22, 2022

Source: fda.gov
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Freshpet Inc. is announcing a voluntary recall of a single lot of Freshpet Select Fresh From the Kitchen Home Cooked Chicken Recipe (4.5 lb. bag), with sell by date of 10/29/22, due to potential contamination with Salmonella. To date, Freshpet has received no reports of illness, injury,... See More or adverse reaction.

The lot may have sold at limited Walmart stores in Alabama and Georgia; and limited Target stores and other select retailers in Connecticut, Massachusetts, Maine, New Hampshire, New Jersey, New York, Pennsylvania, Puerto Rico, Rhode Island, Vermont, and West Virginia.

Freshpet Select Fresh From the Kitchen Home Cooked Chicken Recipe (4.5 lb. bag) with Sell by Date 10/29/22. The Sell by date, along with the UPC code, can be found on the bottom and back of each bag. Please see product pictures below for details.

- FRESHPET® SELECT FRESH FROM THE KITCHEN HOME COOKED RECIPE. UPC: 627975011673. Lot code: 10/29/22. Sell by code: 10/29/22 L3

The Freshpet Team had designated this single lot for destruction, but a small portion of the lot was inadvertently shipped to retailers in limited geographic markets in the last two weeks. No other Freshpet products or lot codes are impacted by this recall.

Salmonella can affect animals eating the product and there is risk to humans, notably children, the elderly, and the immunocompromised, when handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, and fever. Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms.

Consumers exhibiting these signs after having contact with this product should contact their healthcare provider. Dogs with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some dogs will have only decreased appetite, fever, and abdominal pain. Infected but otherwise healthy dogs can be carriers and infect other animals or humans.

If your dog has consumed the recalled product and has these symptoms, please contact your veterinarian. If pet parents have products matching the following description and sell by date in their possession, they should stop feeding it to their dogs and dispose of it immediately. Please call the company 1.800.285.0563 Mon. through Fri., 9 am–9 pm (EDT) and Sat. through Sun. 9 am--1 pm (EDT) if you have any of the recalled product.

Company name: Freshpet Inc.
Brand name: Freshpet
Product recalled: Freshpet Select Fresh From the Kitchen Home Cooked Chicken Recipe
Reason of the recall: Potential Salmonella contamination
FDA Recall date: June 18, 2022

Source: fda.gov
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Latin Foods Market is voluntarily recalling one lot, LOTE 334 21, of Artri King Reforzado con Ortiga y Omega 3 tablets to the consumer level. FDA analysis has found the product to be tainted with diclofenac and dexamethasone. The product was distributed Nationwide in the USA, it... See More was sold online at www.latinfoods.com, and in retail stores. To date, Latin Foods Market has not received any reports of adverse events related to this recall.

Diclofenac and dexamethasone are both FDA approved drugs. Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) indicated for the management of pain and arthritis and dexamethasone is a corticosteroid indicated for a variety of indications including but not limited to arthritis. The presence of diclofenac and dexamethasone in Artri King Reforzado con Ortiga y Omega 3 renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.

Risk Statement: Consumption of undeclared diclofenac could result in serious adverse events that include cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, in those who have allergies to diclofenac, or those with underlying illnesses. Consumption of undeclared dexamethasone may lead to severe and serious adverse events such as adrenal suppression, a disorder in which the adrenal glands do not produce enough hormones, and adverse consequences can range from limited adverse consequences to death.

Artri King Reforzado con Ortiga y Omega 3 is marketed as a dietary supplement for relief of pain and inflammation associated with arthritis and osteoarthritis and is packaged in 100-count tablets per bottle within a cardboard carton, UPC 7 501031 111138. Latin Foods Market will notify all customers who ordered the product online in writing with an email instructing them to discard all recalled products after reviewing the FDA public notification link below and will post a copy of this press release on the Latin Foods Market website and in the retail stores where it was sold.

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

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Latin Foods Market
Brand name: Arti King
Product recalled: Artri King Reforzado con Ortiga y Omega 3
Reason of the recall: Undeclared Diclofenac and Dexamethasone
FDA Recall date: June 14, 2022

Source: fda.gov
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Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray, packaged in 0.3 FL OZ (9ml) bottles to the consumer level. FDA testing found product to contain microbial contamination identified as Providencia rettgeri. To date, Green Pharmaceuticals Inc has not received any reports of adverse events... See More related to this recalled lot.

This microorganism is rarely associated with human illness; however, in immunocompromised patients, the use of the recalled product could potentially result in severe or life-threatening adverse events such as bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, or disseminated fungal infection. In non-immunocompromised patients, the use of the recalled product may result in infectious complications that are expected to be less severe and more readily responsive to treatment.

The product is used as a nasal spray to temporarily help stop or reduce symptoms of non-apneic snoring and is packaged in one single unit plastic bottle with a nasal pump as a delivery system. The affected SnoreStop NasoSpray lot includes the following: 2372/21222 (2373 is printed on a sticker placed on the bottom of the bottle and 21222 is on a sticker placed on the outer packaging).

The product can be identified by a clear transparent plastic box with the name SnoreStop NasoSpray. The product was distributed nationwide in health food stores and online. Green Pharmaceuticals Inc is notifying its retailers and customers by email and is arranging for return and replacement of all recalled products. Consumers and retailers that have product which is being recalled should stop using and return to place of purchase.

Consumers with questions regarding this recall can contact Green Pharmaceuticals Inc by phone at 805-388- 0600, Monday through Friday, 8 AM to 5 PM Pacific Standard Time. 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.

Company name: Green Pharmaceuticals Inc
Brand name: SnoreStop
Product recalled: Nasal spray
Reason of the recall: Due to microbial contamination identified as Providencia rettgeri.
FDA Recall date: June 09, 2022

Source: fda.gov
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Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral... See More Suspension, and two (2) lots of Magnesium Hydroxide 2400 mg/Aluminum Hydroxide 2400 mg/Simethicone 240 mg per 30 mL Oral Suspension to the consumer level. The products are being recalled due to microbial contamination. To date, Plastikon Healthcare has not received any reports of adverse events or injuries related to this recall.

Risk Statement: Administration or use of oral drug products with microbial contamination could potentially result in increased infections that may require medical intervention. Patients with compromised immune systems, such as patients in hospitals and nursing homes, have a higher probability of developing potentially life-threatening infections after taking a contaminated product.

Product indication, lot numbers, expiration dates, and NDC information are listed in the link below. The products are packaged for institutional use and are sold to clinics and hospitals nationwide in single use cups with a foil lid. The affected lots were distributed to Major Pharmaceuticals Distribution Center (wholesaler) between 7/1/2020 and 10/31/2021, who shipped to hospitals, nursing homes, and clinics nationwide. The products are private labeled for Major Pharmaceuticals.

Plastikon Healthcare is notifying its direct customers via a recall letter to arrange for return of any recalled product. Anyone with an existing inventory of the lots which are being recalled should stop use and distribution, and quarantine immediately. Return all quarantined product to the place of purchase. For clinics, hospitals, or healthcare providers that have dispensed product to patients, please notify patients regarding the recall.

Consumers with questions regarding this recall can contact Plastikon Healthcare by phone at (785) 330-7109 Monday through Friday from 9 am to 4 pm CST. 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.

Company name: Plastikon Healthcare, LLC
Brand name: Plastikon Healthcare, LLC
Product recalled: Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension
Reason of the recall: Due to microbial contamination
FDA Recall date: June 08, 2022

Source: fda.gov
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Nottingham, NH, Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast & mold and may contain the bacteria Bacillus cereus.... See More Allergy Bee Gone for Kids Nasal Swab Remedy, lot # 2006491, was distributed Nationwide to wholesale distributors, retail stores and online on Amazon.com and the company web site. Buzzagogo, Inc. places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process.

Risk Statement: In immunocompromised patients, the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, or disseminated fungal infection. In non-immunocompromised patients, the population most likely to use the product, the use of the defective product may result in infectious complications, for instance bacteremia or noninvasive fungal rhinosinusitis, but in this population the infections are expected to be less severe and more readily responsive to treatment. To date, Buzzagogo, Inc. has not received any complaints related to microbial concerns or reports of adverse events related to this recalled lot.

The product is used to lessen seasonal allergy symptoms and is packaged in individual tubes for topical nasal application. The affected Allergy Bee Gone for Kids Nasal Swab Remedy lot is 2006491 with expiration date 8/2024 and UPC code 860002022116. The product can be identified by locating the lot number and expiration date on the bottom of the product carton.

Buzzagogo, Inc. is notifying its distributors and customers by email and is arranging for return or replacement of all recalled products. Consumers, distributors or retailers that have Allergy Bee Gone for Kids Nasal Swab Remedy, lot # 2006491, should stop using the product, and discard any remaining product.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Company name: Buzzagogo Inc.
Brand name: Allergy Bee Gone for Kids
Product recalled: Nasal Swab Remedy
Reason of the recall: Product contains elevated levels of Bacillus cereus
FDA Recall date: June 07, 2022

Source: fda.gov
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Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may result in lung tissue damage due to over-expansion... See More (barotrauma) in the home care environment. The Volara System is distributed in the United States.

These potential events may occur while using the Volara device in line with a ventilator with the required Volara ventilator adaptor or Volara patient circuit kit oscillation and lung expansion (OLE) therapy. This product is manufactured by Hillrom, which was acquired by Baxter in late 2021. As described in the Urgent Medical Device Correction, current patients should continue to use their Volara therapy as prescribed by their physician. Caregivers and/or patients should monitor for signs of respiratory distress (increased breathing rate, wheezing, bluish color around the mouth, inside the lips or in the fingernails, changes in alertness or drop in oxygen level) during Volara therapy when used in line with a ventilator.

Caregivers and/or patients who observe signs of respiratory distress should stop the Volara therapy immediately. If patients do not see improvement after stopping the Volara therapy, they should seek medical attention. Baxter received one report of a patient experiencing oxygen desaturation while using the Volara device in line with a ventilator in a home care environment. This Urgent Medical Device Correction applies to Volara System model numbers PVL1HCBA; M08594; and M08594A with in-line VENTILATOR adaptor (M07937 MODULE, OPTIMUS HANDSET 2) or Volara Patient Circuit Kit (M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT that include M07937).

Company name: Baxter International Inc.
Brand name: Volara
Product recalled: Volara System (home care)
Reason of the recall: Possible risk of oxygen desaturation
FDA Recall date: June 02, 2022

Source: fda.gov
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Walmart Inc. is voluntarily recalling all lots of Artri Ajo King Joint Supplements sold by Innovacion Naturals and PDX Supply Warehouse LLC on Walmart.com and shipped by Walmart to the consumer level. FDA laboratory analysis confirmed that Artri Ajo King Omega 3 Joint Support Supplement with LOTE... See More LTARTKNGOMG30720, CADUCIDAD DICIEMBRE 2026, UPC 7 501031 111190 contains diclofenac not listed on the product label.

Risk Statement: Diclofenac is a non- steroidal anti-inflammatory drug commonly referred to as NSAIDs. NSAIDs (nonsteroidal anti-inflammatory drugs) may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.

This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID- containing products. These products are marketed as dietary supplements and used for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.

Product Description: Artri King Ortiga Omega 3 Joint Support Supplement ArtriKing Nettle Glucosamine Curcumin - 100 ct bottles
UPC: 7 501031 111190
Lot #: All Product lots

Product Description: Artri Ajo King Enhanced Ortiga Omega 3 Curuma Joint Supplement Nettle Glucosamine Tablets- 100 ct bottles
UPC: 7 501031 12705
Lot #: All Product lots

Product Description: ArtriKing Ortiga y Omega 3 Suplemento Alimenticio 100 Tablets (2 Pack) bottles
UPC: 3 72426 01434
Lot #: All Product lots

Product Description: Authentic‼ ARTRI KING Ortiga Omega 3 Joint Support Supplement ArtriKing Nettle 100 ct- bottles
UPC: 6 09002 40885
Lot #: All Product lots

Customers taking these products should immediately talk to their health care provider to safely discontinue use of the product because suddenly stopping diclofenac may be dangerous.

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

Company name: Walmart Inc.
Brand name: Artri Ajo King
Product recalled: Joint supplements
Reason of the recall: Contains diclofenac
FDA Recall date: May 28, 2022

Source: fda.gov
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Albanese Confectionery Group, Inc. of Merrillville, Indiana is voluntarily recalling Albanese® Mini and Giant Peanut Butter Cups because they have 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.

Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

This recall is a direct result of the J.M. Smucker Co. Jif® Peanut Butter recall. This product was not manufactured onsite at Albanese Confectionery Group, Inc. The products were distributed nationwide and reached consumers through select retail stores. The products are sold in bulk bins unpackaged.

Products affected by this recall:
- Rich’s Milk Chocolate Mini Peanut Butter Cups. Sold After: November 11, 2021
- Rich’s Milk Chocolate Giant Layered Peanut Butter Cups. Sold After: January 23, 2022

The full list of retailers where product was sold is available in the link below.

Customers who purchased the above listed product with the associated lot are urged to destroy the product or return it to the place of purchase for a full refund. Consumers with questions may contact the company at (219) 472-6306 Monday – Friday 7:00 AM – 4:00 PM

Company name: Albanese Confectionery Group, Inc.
Brand name: Rich’s
Product recalled: Peanut butter cups
Reason of the recall: Salmonella
FDA Recall date: May 27, 2022

Source: fda.gov
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