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

2 months ago

United States

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 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

465


Related Reports

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
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465


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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465


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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465


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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465


Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples. The product lot... See More was distributed nationwide to wholesalers/hospitals in the United States from July 16, 2020 through July 24, 2020. To date, Pfizer has not received reports of any adverse events associated with this issue for this lot.

Risk Statement: Patients receiving the impacted product have a remote probability of experiencing potential adverse events, such as 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.

Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Propofol Injectable Emulsion 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 Glass Fliptop Vial. The NDC, Lot Number, Expiration Date, and Configuration details for Propofol Injectable Emulsion are indicated below.

Product: Configuration/Count Propofol Injectable Emulsion, 100 mL Single Patient Use Glass Fliptop Vial
NDC: Vial: 0409-4699-54 Tray: 0409-4699-24
Lot Number: EA7470
Expiration Date: 01 JUNE 2023
Presentation: 1g/100 mL, Single Patient Use Glass Fliptop Vial
Configuration/Count: Tray of 10 Units

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 or hospitals with an existing inventory of the lot, which is being recalled, should discontinue use, stop distribution and quarantine immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. 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: August 22, 2022

Source: fda.gov
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465


Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to a limited number of stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, and UT on... See More or around May 1, 2022 through June 21, 2022 due to product being stored outside of labeled temperature requirements. To date, Family Dollar is not aware of any consumer complaints or reports of illness related to this recall.

- Products covered by this retail level recall include:

998277 COLGATE OPTIC WHITE STAIN PREVENTION TOOTHPASTE 2.1OZ
998909 COLGATE OPTIC WHITE CHARCOAL TOOTHPASTE 4.2OZ
999043 COLGATE OPTIC WHITE MOUTHWASH 16 FL OZ
999088 COLGATE OPTIC WHITE HIGH IMPACT TOOTHPASTE 3OZ
999749 COLGATE OPTIC WHITE TOOTHPASTE ICY FRESH 3.2OZ
999750 COLGATE OPTIC WHITE STAIN FIGHTER TOOTHPASTE CLEAN MNT 4.2OZ

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: Family Dollar
Brand name: Colgate
Product recalled: Toothpaste
Reason of the recall: Product was stored outside of labeled temperature requirements
FDA Recall date: September 16, 2022

Source: fda.gov
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7


Salon Technologies International. Inc. is voluntarily recalling one lot of Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%, Lot 1166A. Expiration 6/18/2023 to the consumer level. Firm lab testing has found the product to contain benzene. Benzene is classified as a human carcinogen. Exposure to benzene can... See More occur by inhalation, orally, and through the skin. Depending on duration and level of exposure, it can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening.

Salon Tech International, Inc. has not received any reports of adverse events related to this recall. The product is used to help reduce bacteria, that potentially can cause disease, when soap and water are not available. 512 bottles of Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%, Lot 1166A, Expiration 6/18/2023 was distributed in the Seattle, Washington area.

Salon Technologies International. Inc. has notified its distributors by email and is arranging for return of all recalled products. Consumers that have product which is being recalled should stop using and return unused product to where it was obtained.

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: Salon Technologies International Inc.
Brand name: Antica Farmacista
Product recalled: Ocean Citron Hand Sanitizer
Reason of the recall: Product contains benzene
FDA Recall date: September 19, 2022

Source: fda.gov
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1.6K


East Windsor, New Jersey, Eugia US LLC (formerly AuroMedics Pharma LLC) has initiated a voluntary recall of lot number AC22006 of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single dose vial to the consumer level from the U.S. market due to... See More a product complaint for the presence of a dark red, brown and black particulate inside the vial.

Risk Statement: The administration of an intravenous product containing particulates has the potential to result in inflammation, allergic reactions, or circulatory system complications which could be life-threatening. To date, Eugia US LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed for this lot.

AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), contains acyclovir, a synthetic nucleoside analog, active against herpes viruses. Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV- 1 and HSV-2) in immunocompromised patients and initial clinical episodes of herpes genitalis in immuno-competent patients. It is packaged in a glass vial labeled with NDC 55150-154-10. The lot being recalled is AC22006 with an expiration date of 08/2023. Eugia US LLC shipped the entire lot to wholesalers nationwide from June 8, 2022, through June 13, 2022.

The product label is as shown below: Eugia US LLC is notifying its direct consignees by recall letters and is arranging for return/ replacement of all recalled products. Wholesale customers and health professionals that have the product lot which is being recalled should immediately place the recalled lot on hold.

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. 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: Eugia US LLC
Brand name: Auromedics
Product recalled: Acyclovir Intravenous Product
Reason of the recall: Presence of a dark red, brown and black particulate inside the vial
FDA Recall date: September 27, 2022

Source: fda.gov
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465


Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill lot 20210912 and lot 31853-501, expiry 09/24, packaged in 10-count blisters co-packaged in a carton and in 60-count bottles to the consumer level. Proper Trade LLC/My Stellar Lifestyle was notified by Amazon that laboratory analysis has found... See More the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in Wonder Pill capsules makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.

Consumers with underlying medical issues who take the Wonder Pill with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Proper Trade LLC/ My Stellar Lifestyle has not received any reports of adverse events related to this recall.

The product is marketed as a dietary supplement for male sexual enhancement and is packaged in 10-count blisters co-packaged in a carton, ASIN B0B6CWC9NK, and packaged in a 60-count bottle. The affected lots include lot numbers’ 20210912 & 31853-501, Expiry 09/24. The product can be identified by the labels below. The product was distributed via the internet and fulfilled by Amazon at www.amazon.com and Walmart at www.walmart.com, nationwide in the USA.

On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Proper Trade LLC/ My Stellar Lifestyle is notifying its customers by this press announcement and sending Amazon & Walmart messages to its customers and is arranging for return of all recalled products. Consumers that have Wonder Pill capsules which is being recalled should stop using the product.

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. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

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

Company name: Proper Trade LLC/My Stellar Lifestyle
Brand name: My Stellar Lifestyle
Product recalled: Wonder Pill Capsules
Reason of the recall: Product contains undeclared tadalafil
FDA Recall date: September 28, 2022

Source: fda.gov
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465


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Lake Byllesby beach has been closed until further notice by Dakota County due to high E. coli levels. Beach water testing will resume on Tuesday, Sept. 6 when the lab reopens. Dakota County will notify the public when E.coli levels are safe for beach visitors.

Source: co.dakota.mn.us See Less
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One of You’re big rig 3 axle trucks is driving down this road Country Club drive Roseville CA, 8:15 am. 09/09/2022 (he was also speeding). this is not a truck route! Amazon is in violation of the FMCSA rules. See Less
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East Windsor, New Jersey, Eugia US LLC (formerly AuroMedics Pharma LLC) has initiated a voluntary recall of lot number AC22006 of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single dose vial to the consumer level from the U.S. market due to... See More a product complaint for the presence of a dark red, brown and black particulate inside the vial.

Risk Statement: The administration of an intravenous product containing particulates has the potential to result in inflammation, allergic reactions, or circulatory system complications which could be life-threatening. To date, Eugia US LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed for this lot.

AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), contains acyclovir, a synthetic nucleoside analog, active against herpes viruses. Acyclovir Sodium Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV- 1 and HSV-2) in immunocompromised patients and initial clinical episodes of herpes genitalis in immuno-competent patients. It is packaged in a glass vial labeled with NDC 55150-154-10. The lot being recalled is AC22006 with an expiration date of 08/2023. Eugia US LLC shipped the entire lot to wholesalers nationwide from June 8, 2022, through June 13, 2022.

The product label is as shown below: Eugia US LLC is notifying its direct consignees by recall letters and is arranging for return/ replacement of all recalled products. Wholesale customers and health professionals that have the product lot which is being recalled should immediately place the recalled lot on hold.

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. 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: Eugia US LLC
Brand name: Auromedics
Product recalled: Acyclovir Intravenous Product
Reason of the recall: Presence of a dark red, brown and black particulate inside the vial
FDA Recall date: September 27, 2022

Source: fda.gov
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Did my first SHEIN haul, was excited to open it, but the toxic odor coming from the products was unreal. It hit me hard, I ended up getting a headache out of the shoes especially. I had to put everything outside to air for 24 hours. I... See More do not know what they use to make the product, but beware especially if opening around babies or children.

The smell subsided after airing, and the products were ok to use. | Symptoms: Headache
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Spot and Tango announced the recall of 4 batches of their Chicken and Brown Rice UnKibble Dog Food because samples tested positive for Salmonella bacteria.

The recalled product is Chicken and Brown Rice UnKibble Dog Food, with the codes:
-Lot Code T-22220 and SKU Number U-C-004
-... See More Lot Code T-22223 and SKU Number U-C-005
- Lot Code T-22220 and SKU Number U-C-006
- Lot Code T-22228 and SKU Number U-C-003

No other Spot & Tango products are affected by this recall.

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

Dogs with Salmonella infections will most likely not exhibit any symptoms, though in rare cases they may be lethargic and have diarrhea (which may be bloody), fever, and vomiting. Some dogs may have only decreased appetite, fever, and abdominal pain. Infected but otherwise healthy dogs can be carriers and infect other animals or humans through the fecal-oral route.

If you have the recalled product in your home, please stop feeding it to your dogs and dispose of it immediately.

Source: dogfoodadvisor.com
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