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Magnesium Citrate Saline Laxative Oral Solution - recalled due to microbial contamination, USA

4 days ago

United States

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 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 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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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 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.

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Source: fda.gov
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Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level. The product was distributed Nationwide to wholesale and retail outlets. To date, Vi-Jon, LLC... See More has received one report of an adverse reaction potentially related to this recall.

The recall was initiated after 3rd Party and Vi-Jon, LLC 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.

Vi-Jon, LLC is in the process of investigating this report. 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.

The affected brands of Magnesium Citrate Laxative Oral Solution Lemon Flavor manufactured at Vi-Jon, LLC in Smyrna, TN are:

- Affected Brand: BEST CHOICE 10OZ LEMON MAG CIT. NDC # 63941-533-38. UPC # 70038200499.
- Affected Brand: CARE ONE 10OZ LEMON MAG CIT. NDC # 72476-001-38. UPC # 341520313226.
- Affected Brand: CARIBA 10OZ LEMON MAG CITRATE. NDC # 67860-166-38. UPC # 646702057012.
- Affected Brand: CRUZ BLANC 10OZ LEMON MAG CIT. NDC # N/A. UPC # 308697403082.
- Affected Brand: CVS 10OZ LEMON MAG CIT. NDC # 63868-929-38. UPC # 50428335178.
- Affected Brand: CVS 10OZ LEMON MAG CIT. NDC # 69842-983-38. UPC # 50428305942.
- Affected Brand: DISCOUNT DRUG MART 10OZ LEMON MAG CITRATE. NDC # 53943-166-38. UPC # 93351028205.
- Affected Brand: EQUALINE 10OZ LEMON MAG CIT. NDC # 41163-709-38. UPC # 41163500679.
- Affected Brand: EQUATE 10OZ LEMON MAG CIT SRP. NDC # 49035-506-38. UPC # 681131287142.
- Affected Brand: EXCHANGE SELECT 10OZ LEMON MAG CIT. NDC # 55301-166-38. UPC # 614299404205.
- Affected Brand: FAMILY WELLNESS 10OZ LEMON CITRATE. NDC # 55319-666-38. UPC # 32251580826.
- Affected Brand: GOOD SENSE 10OZ LEMON MAG CIT. NDC # 50804-166-38. UPC # 846036007374.
- Affected Brand: HARRIS TEETER 10OZ LEMON MAG CITRATE. NDC # 72036-002-38. UPC # 72036726124.
- Affected Brand: HEB 10OZ LEMON MAG CITRATE. NDC # 37808-769-38. UPC # 41220510863.
- Affected Brand: HEALTH MART 10OZ LEMON MAG CIT. NDC # 62011-0380-1. UPC # 52569142158.
- Affected Brand: KROGER 10OZ LEMON MAG CITRATE. NDC # 30142-899-38. UPC # 41260001826.
- Affected Brand: LEADER 10OZ LEMON MAG CIT. NDC # 70000-0424-1. UPC # 96295135541.
- Affected Brand: MAJOR 10OZ LEMON MAG CITRATE. NDC # 0904-6787-44. UPC # 309046787440.
- Affected Brand: MEIJER 10OZ LEMON MAG CIT. NDC # 41250-708-38. UPC # 713733459457.
- Affected Brand: PREMIER VALUE 10OZ LOW SOD LEM CIT. NDC # 68016-696-38. UPC # 840986035302.
- Affected Brand: PUBLIX 10OZ LEMON MAG CIT. NDC # 56062-266-38. UPC # 41415506732.
- Affected Brand: QUALITY CHOICE 10OZ LEMON MAG CIT. NDC # 63868-929-38. UPC # 635515901254.
- Affected Brand: REXALL 10OZ LEMON MAG CITRATE. NDC # 55910-183-38. UPC # 72785134188.
- Affected Brand: RITE AID 10OZ LEMON CITRATE. NDC # 11822-4330-2. UPC # 11822433006.
- Affected Brand: SIGNATURE CARE 10OZ LEMON MAG CIT. NDC # 21130-709-38. UPC # 321130779155.
- Affected Brand: SOUND BODY 10OZ LEMON MAG CIT. NDC # 50594-166-38. UPC # 72785114791.
- Affected Brand: SUNMARK 10OZ LEMON MAG CIT. NDC # 70677-0051-1. UPC # 10939908445.
- Affected Brand: SWAN 10OZ LEMON MAG CITRATE. NDC # 0869-0166-38. UPC # 72785134058.
- Affected Brand: TOPCARE 10OZ LEMON MAG CITRATE. NDC # 36800-709-38. UPC # 36800455290.
- Affected Brand: UP&UP 10OZ LEMON MAG CIT. NDC # 11673-708-38. UPC # 72785128835.
- Affected Brand: UP&UP 10OZ LEMON MAG CIT. NDC # 11673-666-38. UPC # 72785128835.
- Affected Brand: WALGREENS 10OZ LEMON MAG CIT. NDC # 0363-8166-38. UPC # 311917201603.

Vi-Jon, LLC is continuing their investigation into the cause of the problem. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company name: Vi-Jon, LLC
Brand name: Multiple brand names
Product recalled: Magnesium Citrate Saline Laxative Oral Solution, Lemon Flavor
Reason of the recall: Microbial contamination with Gluconacetobacter liquefaciens
FDA Recall date: July 15, 2022

Source: fda.gov
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Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), 100 mL Single Patient Use Glass Fliptop Vial; lot DX9067, to the user level due to a visible particulate observed in a single vial during annual examination of retain... See More samples. The product lot was distributed nationwide to wholesalers/ hospitals/Department of Defense in the United States from June 10, 2020 through June 26, 2020.

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Risk Statement: Patients receiving the impacted product are at risk of experiencing life-threatening adverse clinical effects including but not limited to: blockage of blood vessels, including decreased blood flow to the brain, heart attack, pulmonary embolus, and tissue necrosis. Hypersensitivity reactions and transmission of infectious disease can also occur.

To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion, USP is a terminally sterilized (TS) product. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a single patient use fliptop vial.

Wholesalers or hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately. If you have further distributed the recalled product, to the wholesale or hospital level/institution, please notify any accounts or additional locations which may have received the recalled product from you. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.

Company name: Hospira Inc, A Pfizer Company
Brand name: Hospira
Product recalled: Propofol Injection Emulsion, USP
Reason of the recall: Potential presence of visible particulate
FDA Recall date: July 13, 2022

Source: fda.gov
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I ordered 2 Stihl battery operated chainsaws on 7/15/22 order #22071603394 What I received today was 2-10packs of F*CKING tooth brushes from China!!!!!! I called my credit card company and told them about YOUR HUGE SCREW UP and they are looking into IT!! You can refund my... See More $65.12 to my credit card IMMEDIATELY! My package came from 1555 N Chrisman Rd Tracy, CA WHICH is your address.

I saw the ad for the Stihl saws on Facebook. There were multiple offers for the SAME saw and I chose the deal from (95bb04) .
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This product was found to contain the undeclared active pharmaceutical ingredient tadalafil. Tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor, is the active ingredient in an FDA-approved prescription drug, used to treat erectile dysfunction (ED). Product was sold through our website, wholesaleonline1.com Mar 2022 to July 2022... See More and ­ distributed in any US State. To date, wholesaleonline1.comhas not received any reports of adverse events related to this recall.

The product comes in a black box and contains 12 sachets of 15 grams of honey with different expiration dates stamped on the back side. This undeclared ingredient (tadalafil) may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

The recall was initiated after FDA laboratory analysis confirmed that Dose Vital VIP Vital Honey contains the undeclared active pharmaceutical ingredient Tadalafil. Consumers who have purchased Vital Honey on wholesaleonline1.com are urged to immediately discontinue use and return the recalled product for a full refund.

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: MKS Enterprise LLC
Brand name: Dose Vital
Product recalled: Honey
Reason of the recall: Undeclared active pharmaceutical ingredient tadalafil
FDA Recall date: July 19, 2022

Source: fda.gov
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456


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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