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

1 week 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

456


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DISTRIBUTOR RFR, LLC. is voluntarily recalling lot #48656, Exp. 01/2025 of SANGTER Energy Supplement, 3000 mg, packaged in 7-count blister packs within a carton to the consumer level. FDA analysis has found the product to contain undeclared sildenafil. Sildenafil is a phosphodiesterase (PDE-5) inhibitor found in FDA-approved... See More products for the treatment of male erectile dysfunction. The presence of sildenafil in SANGTER makes it an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall. To date, DISTRIBUTOR RFR, LLC. has not received any reports of adverse events related to this recall.

The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in a 7-count blister pack within a carton, UPC 0 705632 523285, and was distributed through retail stores in the state of Florida from 02/01/2002 to 07/20/2022 and Nationwide in the USA through our website from 02/01/2002 to 07/20/2022  www.sangter.com.

Distributor RFR, LLC is notifying its distributors and customers through this notice and is arranging for the return of all recalled products. All customers are urged to stop consuming the product marked with this lot, and to contact their physician or health care provider if they have experienced any problems that may be related to taking or using this medication.

Risk Statement: Use of SANGTER with undeclared sildenafil may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are at the most at risk from these products.

Company name: Distributor RFR, LLC
Brand name: SANGTER
Product recalled: SANGTER Energy Supplement, 3000mg
Reason of the recall: Undeclared Sildenafil
FDA Recall date: August 02, 2022

Source: fda.gov
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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
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456


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
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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.

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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.

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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 recalled product is:
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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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Belleville and Newark have issued boil water advisories after a major main break near Branch Brook Park. Water pressure and service was affected in both municipalities.

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DISTRIBUTOR RFR, LLC. is voluntarily recalling lot #48656, Exp. 01/2025 of SANGTER Energy Supplement, 3000 mg, packaged in 7-count blister packs within a carton to the consumer level. FDA analysis has found the product to contain undeclared sildenafil. Sildenafil is a phosphodiesterase (PDE-5) inhibitor found in FDA-approved... See More products for the treatment of male erectile dysfunction. The presence of sildenafil in SANGTER makes it an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall. To date, DISTRIBUTOR RFR, LLC. has not received any reports of adverse events related to this recall.

The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in a 7-count blister pack within a carton, UPC 0 705632 523285, and was distributed through retail stores in the state of Florida from 02/01/2002 to 07/20/2022 and Nationwide in the USA through our website from 02/01/2002 to 07/20/2022  www.sangter.com.

Distributor RFR, LLC is notifying its distributors and customers through this notice and is arranging for the return of all recalled products. All customers are urged to stop consuming the product marked with this lot, and to contact their physician or health care provider if they have experienced any problems that may be related to taking or using this medication.

Risk Statement: Use of SANGTER with undeclared sildenafil may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are at the most at risk from these products.

Company name: Distributor RFR, LLC
Brand name: SANGTER
Product recalled: SANGTER Energy Supplement, 3000mg
Reason of the recall: Undeclared Sildenafil
FDA Recall date: August 02, 2022

Source: fda.gov
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Source: fda.gov
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