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Vi-Jon, LLC Magnesium Citrate Saline Laxative Oral Solution - recalled due to bacterial contamination, USA

3 weeks ago

United States

Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry to the consumer level.  This expansion includes all lots of Cherry Flavor and Grape Flavor of Magnesium Citrate Saline Laxative Oral Solution, 10 FL OZ (296 mL)  within expiry. On July 14, 2022, Vi-Jon, LLC recalled all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry. The product was distributed Nationwide to wholesale and retail outlets. To date, Vi-Jon, LLC is aware of 3 (three) reports of serious adverse reactions potentially related to this recall.

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. The recall was initiated after Vi-Jon, LLCs third party microbial testing identified the presence of Gluconacetobacter liquefaciens. Vi-Jon, LLC is continuing their investigation into the cause of the problem.

The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. In addition to the lemon flavor, the recall now includes the Cherry flavor and Grape flavor noted below in the table in bold print. Affected Brand, NDC #, UPC # information are listed in the link below.

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: Vi-Jon, LLC
Brand name: Multiple Brands
Product recalled: Magnesium Citrate Saline Laxative Oral Solution
Reason of the recall: Potential Gluconacetobacter liquefaciens contamination
FDA Recall date: July 26, 2022

Source: fda.gov

459


Related Reports

Plastikon Healthcare, LLC is issuing an update to the voluntary recall initiated on June 3, 2022.  The recall has been expanded to include Lot 20076A of Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension. The products are... See More being recalled due to microbial contamination. To date, Plastikon Healthcare has not received any reports of adverse events or injuries related to this recall.

This lot was previously subject to a retail level recall and has been added to the current consumer level recall based on updated microorganism speciation data from third-party testing. The updated recall includes 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, twelve (12) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL Oral 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. 

Risk Statement: Administration or use of 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 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.

Product Name: Milk of Magnesia, 2400 mg / 30 mL, Oral Suspension.
Indications for Use: Occasional relief of constipation, (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor.
Lot/Exp: 20071A / Jul. 2022
NDC: 0904-6846-73
Packaging: Carton containing, 100 single dose cups (10 trays x 10 cups).

Product Name: Milk of Magnesia, 2400 mg / 10 mL, Oral Suspension.
Indications for Use: Occasional relief of constipation, (irregularity) in adults and children 12 years and older or for children under 12 as recommended by a doctor.
Lot/Exp: 20074A / Jul. 2022
NDC: 0904-6840-72
Packaging: Carton containing, 100 single dose cups (10 trays x 10 cups).

Product Name: Magnesium, Hydroxide 1200 mg / Aluminum, Hydroxide 1200 mg/ Simethicone 120 mg per 30 mL Oral Suspension.
Indications for Use: Relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating
commonly referred to as gas.
Lot/Exp: 21103A / Sep. 2023, 20046A / May 2022, 20076A / Jul. 2022, 20079A / Aug. 2022, 20080A / Aug. 2022, 20081A / Aug. 2022, 21057A / May 2023, 21059A / May 2023, 21095A / Sep. 2023, 21096A / Sep. 2023, 21099A / Sep. 2023, 21115A / Oct. 2022
NDC: 0904-6838-73
Packaging: Carton containing 100 single dose cups (10 trays x 10 cups).

Product Name: Magnesium Hydroxide 2400 mg / Aluminum, Hydroxide 2400 mg / Simethicone, 240 mg per 30 mL Oral Suspension.
Indications for Use: Relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, pressure and bloating
commonly referred to as gas.
Lot/Exp: 20051A / Aug. 2022, 20088A / Sep. 2022
NDC: 0904-6839-73
Packaging: Carton containing 100 single dose cups (10 trays x 10 cups).

Company name: Plastikon Healthcare, LLC
Brand name: Major
Product recalled: Milk of Magnesia, Magnisium Hydroxide/Aluminum Hydroxide/Simethicone Oral Suspension
Reason of the recall: Microbial contamination
FDA Recall date: August 04, 2022

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

Source: fda.gov
See Less
459


Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry that were voluntarily recalled to the consumer level to include product that was distributed in the United States, Canada and Panama. This includes all lots of Cherry... See More Flavor and Grape Flavor of Magnesium Citrate Saline Laxative Oral Solution, 10 FL OZ (296 mL) within expiry. To date, Vi-Jon, LLC is aware of 3 (three) reports of serious adverse reactions potentially related to this recall. Vi-Jon, LLC is in the process of investigating these reports.

On July 14, 2022, Vi-Jon, LLC recalled all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry. The recall was initiated after Vi-Jon, LLCs third party microbial testing identified the presence of Gluconacetobacter liquefaciens.

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. The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. In addition to the lemon flavor, the recall includes the Cherry flavor and Grape flavor.

On August 3, 2022, the Recall product list has been updated to include the products noted below.

CANADA Equate Canada 300 mL Lemon Magnesium Citrate
NPN # NPN 80015316
UPC # 079068004923

CANADA Life 300 mL Lemon Magnesium Citrat
NPN # NPN 80015316
UPC # 057800856412

CANADA Life 300 mL Cherry Magnesium Citrate
NPN # NPN 80015316
UPC # 057800856405

CANADA Personnelle 300 mL Lemon Citrate
NPN # NPN 80015316
UPC # 055989029306

PANAMA CRUZ BLANC 10OZ LEMON MAG CIT
NPN # N/A
UPC # 308697403082

The product was distributed in the United States, Canada and Panama to wholesale and retail outlets. Vi-Jon, LLC is continuing their investigation into the cause of the problem.

Vi-Jon, LLC is notifying its customers by phone and email and is arranging for return or destruction 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 from these products, 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: Multiple brand names
Product recalled: Magnesium Citrate Saline Laxative Oral Solution
Reason of the recall: Microbial contamination with Gluconacetobacter liquefaciens
FDA Recall date: August 04, 2022

Source: fda.gov
See Less
459


The FDA is cautioning pet owners not to feed their pets certain lots of Darwin’s Natural Pet Products raw cat food after samples from these lots tested positive for Salmonella, and they represent a serious threat to human and animal health. These products are manufactured by Arrow... See More Reliance Inc., doing business as Darwin’s Natural Pet Products, and are sold online direct to consumers. These foods have been associated with cases of illness in three kittens in a single household.

The FDA recommended that Arrow Reliance Inc. voluntarily recall these products and notify the public, but the company has not done so.

The affected products are:
- Darwin’s Natural Pet Products Natural Selections Antibiotic & Grain Free Chicken Recipe for Cats, Lot 9116, manufactured on May 2, 2022.
- Darwin’s Natural Pet Products Natural Selections Antibiotic & Grain Free Turkey Recipe for Cats, Lot 9121, manufactured on May 4, 2022.

The products are sold in white and clear plastic packages with blue and green labeling. Each pack weighs two pounds and consists of four separate units. The lot codes are on the front lower left unit of the package.

If you have these lots of Darwin’s Natural Pet Food, or you can’t be sure of the lot code of the products you have, throw them away. Do not feed them to your pets.

Pet foods contaminated with Salmonella are of particular public health importance because they can affect both human and animal health. Pets can get sick from Salmonella and may also be carriers of the bacteria and pass it on to their human companions without appearing to be ill. People who think their pets have become ill after consuming contaminated pet food should first contact their veterinarians.

In case you are experiencing Salmonella symptoms such as diarrhea, abdominal cramps, and fever, 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. If symptoms persist, seek medical care.

Source: fda.gov
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The CFIA announced the recall of raw frozen Primal Patties for Dogs Beef Formula because it may be contaminated with Listeria monocytogenes, posing a risk of cross-contamination and illness after handling the pet food. This product was sold in British Columbia. As of August 2, 2022, the... See More company has not received any reports of incidents or illness in Canada.

The recalled product is:
- Primal Patties – Beef Formula, 6 lb, Case UPC: 854495006173, Unit UPC: 850334004164, Lot code number: W10068709, Best by date: 05/22/23.

The lot code number and best by date can be found on the back of the product packaging above the Primal Pet Foods Inc. red oval logo. Only lot code number W10068709 is included is this recall.

Animals that become infected with Listeria monocytogenes could display symptoms similar to humans. Listeria monocytogenes can affect animals eating the product, and there is risk to humans from handling the products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to the products.

Consumers should immediately stop using the recalled product and dispose of the product.

In case you are experiencing Listeria monocytogenes symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, 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. If symptoms persist, seek medical care. If symptoms persist, seek medical care.

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On August 18, 2022, the City of Sulphur announced that due to a water main break, pressure may have dipped below the required levels in parts of the city. For this reason, a precautionary boil advisory has been issued in the affected areas from Maplewood Drive to... See More Oakley Drive and Sylvan Oaks Drive to Palermo Drive.

Source: twitter.com
Published: 2022-08-18
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New Creek Water Association Inc. has LIFTED the boil water advisory for the Hooker Hollow Road, Crestwood, Hidden View, Hershey Hollow Road, Graysons Gap, Northwestern Turnpike, and Cut Off Road areas.

Source: twitter.com
Published: 2022-08-18 See Less


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Published: 2022-08-18 See Less


Beckley Water Company has LIFTED the boil water advisory for the Sweeneysburg Road, Maple Fork Road, Burn Bowyer Road, Clearfork Road, and Tillus Lane areas.

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Published: 2022-08-18 See Less


Gauley River PSD has LIFTED the boil water advisory for the Brownsville, Alta, Belva, Dixie, Bentree, Bell Creek, and Mt. Olive areas.

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Recent Interesting Reports

The Washtenaw County Health Department and the Washtenaw County Parks and Recreation Commission announced that Independence Lake beach has been closed for swimming the due to high levels of E. coli bacteria. The beach will reopen once follow-up tests confirm levels are low enough to safely swim... See More again.

According to the news this is the third time officials have closed Independence Lake beach this summer due to high levels of E. coli bacteria

Source: clickondetroit.com
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581


Wilbur’s of Maine Chocolate Confections of Freeport, Maine is recalling its 8 oz resealable package of milk chocolate covered blueberries because they may contain undeclared chocolate covered almonds. People who have allergies to almonds run the risk of serious or life-threatening allergic reaction if they consume these... See More products. The recalled Milk Chocolate Blueberries were distributed throughout New England, in retail stores, and nationwide through mail orders. No illnesses have been reported to date in connection with this problem.

The product comes in Wilbur’s branded 8-ounce, resealable zippered pouch bag, with UPC # 81321300430 and an expiration date of April 5, 2023 stamped on the backside.

The recall was initiated after a customer discovered chocolate covered almonds in a package (of milk chocolate covered blueberries). The blueberry packaging does not reveal the presence of almonds. Consumers with nut allergies, who have purchased 8 oz packages of milk chocolate covered blueberries, with the best by date of 4/5/23, are encouraged to return them to place of purchase for a full refund.

Subsequent investigation indicates that the problem was caused by a temporary breakdown in the company’s packaging process. The process has been corrected and the company has instituted additional safety checks and corrective actions.

In case you experienced harm from allergens or undeclared ingredients, 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: Wilbur’s of Maine Chocolate Confections
Brand name: Milk chocolate covered blueberries
Product recalled: Milk chocolate covered blueberries
Reason of the recall: Undeclared almonds
FDA Recall date: July 28, 2022

Source: fda.gov
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I received a 10cent plastic fan in a mailer. So I am assuming they are going to use the tracking number to show I did receive a pkg. But a 10 cent plastic fan is not a piece of furniture to store craft items. See Less
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The CFIA announced the recall of raw frozen Primal Patties for Dogs Beef Formula because it may be contaminated with Listeria monocytogenes, posing a risk of cross-contamination and illness after handling the pet food. This product was sold in British Columbia. As of August 2, 2022, the... See More company has not received any reports of incidents or illness in Canada.

The recalled product is:
- Primal Patties – Beef Formula, 6 lb, Case UPC: 854495006173, Unit UPC: 850334004164, Lot code number: W10068709, Best by date: 05/22/23.

The lot code number and best by date can be found on the back of the product packaging above the Primal Pet Foods Inc. red oval logo. Only lot code number W10068709 is included is this recall.

Animals that become infected with Listeria monocytogenes could display symptoms similar to humans. Listeria monocytogenes can affect animals eating the product, and there is risk to humans from handling the products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to the products.

Consumers should immediately stop using the recalled product and dispose of the product.

In case you are experiencing Listeria monocytogenes symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea, 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. If symptoms persist, seek medical care. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca
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Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry to the consumer level.  This expansion includes all lots of Cherry Flavor and Grape Flavor of Magnesium Citrate Saline Laxative Oral Solution,... See More 10 FL OZ (296 mL)  within expiry. On July 14, 2022, Vi-Jon, LLC recalled all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry. The product was distributed Nationwide to wholesale and retail outlets. To date, Vi-Jon, LLC is aware of 3 (three) reports of serious adverse reactions potentially related to this recall.

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. The recall was initiated after Vi-Jon, LLCs third party microbial testing identified the presence of Gluconacetobacter liquefaciens. Vi-Jon, LLC is continuing their investigation into the cause of the problem.

The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. In addition to the lemon flavor, the recall now includes the Cherry flavor and Grape flavor noted below in the table in bold print. Affected Brand, NDC #, UPC # information are listed in the link below.

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: Vi-Jon, LLC
Brand name: Multiple Brands
Product recalled: Magnesium Citrate Saline Laxative Oral Solution
Reason of the recall: Potential Gluconacetobacter liquefaciens contamination
FDA Recall date: July 26, 2022

Source: fda.gov
See Less
459


Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry that were voluntarily recalled to the consumer level to include product that was distributed in the United States, Canada and Panama. This includes all lots of Cherry... See More Flavor and Grape Flavor of Magnesium Citrate Saline Laxative Oral Solution, 10 FL OZ (296 mL) within expiry. To date, Vi-Jon, LLC is aware of 3 (three) reports of serious adverse reactions potentially related to this recall. Vi-Jon, LLC is in the process of investigating these reports.

On July 14, 2022, Vi-Jon, LLC recalled all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry. The recall was initiated after Vi-Jon, LLCs third party microbial testing identified the presence of Gluconacetobacter liquefaciens.

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. The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. In addition to the lemon flavor, the recall includes the Cherry flavor and Grape flavor.

On August 3, 2022, the Recall product list has been updated to include the products noted below.

CANADA Equate Canada 300 mL Lemon Magnesium Citrate
NPN # NPN 80015316
UPC # 079068004923

CANADA Life 300 mL Lemon Magnesium Citrat
NPN # NPN 80015316
UPC # 057800856412

CANADA Life 300 mL Cherry Magnesium Citrate
NPN # NPN 80015316
UPC # 057800856405

CANADA Personnelle 300 mL Lemon Citrate
NPN # NPN 80015316
UPC # 055989029306

PANAMA CRUZ BLANC 10OZ LEMON MAG CIT
NPN # N/A
UPC # 308697403082

The product was distributed in the United States, Canada and Panama to wholesale and retail outlets. Vi-Jon, LLC is continuing their investigation into the cause of the problem.

Vi-Jon, LLC is notifying its customers by phone and email and is arranging for return or destruction 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 from these products, 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: Multiple brand names
Product recalled: Magnesium Citrate Saline Laxative Oral Solution
Reason of the recall: Microbial contamination with Gluconacetobacter liquefaciens
FDA Recall date: August 04, 2022

Source: fda.gov
See Less
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