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AVpak Senna Syrup 5mL - recalled due to potential microbial contamination, USA

6 months ago

United States

Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is being recalled due to microbial contamination. Use of contaminated product by the elderly, patients with a weakened immune system, or patients at a higher risk of developing life-threatening inflammation of the heart, could result in infections that could be life-threatening.

To date, Lohxa LLC has not received any reports of adverse events related to this recall.

The product is used as a natural vegetable laxative for the relief of occasional constipation and is packaged into 5 mL unit-dose cups. The product is distributed into cases of 20 cartons packaged with 24 units each, NDC: 50268-731-24. The affected Senna Syrup 8.8mg/5mL lot is AM1115S with expiration date of 01/2023. The product can be identified by the label attached.

Product was distributed to AvKare (Wholesaler) who may have further distributed this to clinics, hospitals, and healthcare providers. Outer carton labeling (see images) Unit-Dose Cups (see image) Lohxa LLC is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using the product and return it to place of purchase.

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.

Company name: Lohxa LLC
Brand name: AVpak
Product recalled: Senna Syrup 5mL
Reason of the recall: Potential microbial contamination
FDA Recall date: January 12, 2022

Check the full recall details on fda.gov

Source: FDA

459


Related Reports

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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458


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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458


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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458


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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458


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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Grant County PSD has LIFTED the boil water advisory for the Huffman Drive, Rough Run, Spring Run, Boot Hill, Creite Village, Turkey Knob, and Tom Cox Road areas.

Source: twitter.com
Published: 2022-08-11 See Less
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Today the Shippensburg Borough Authority had a water main break and is implementing precautionary boil water advisory. Affected customers include:
Eberly Drive
Logan Lane
Baker & Russell Drive
Volvo Way
Rowe Road

Source: twitter.com
Published: 2022-08-11 See Less
171


Recent Interesting 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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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) .

08/08 update: Still waiting for the CORRECT PACKAGE to be DELIVERED or the return of my $65.12!!!!!
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Item was arrived 07-30 -22 Teterboro. I didn’t receive my order from Jlo Beauty tracking number should is in Teterboro since 7-30-22. Tracking number is 9261290278840003. See Less
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Encore is recalling Beef Selection in Gravy multipack dog food because the Beef Steak with Potatoes in Gravy tin, within the multipack, may contain small pieces of metal. This product was distributed nationwide in the United Kingdom.

Encore Beef Selection in Gravy (Multipack) (5 tins x 156g)... See More Batch code: LU1-343
Best before: 09 December 2024

Encore Beef Selection in Gravy (Multipack) (5 tins x 156g)
Batch code: LU1-302
Best before: 29 October 2024

Encore Beef Steak with Potatoes in Gravy (Individual tin) (156g)
Batch code: LU1343D
Best before: December 2024

Pet-owners: We urge customers who have bought this product not to feed it to their dog and return it to the store with or without a receipt from where it was bought for a full refund.

In case your pet experienced harm from extraneous materials, 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: Encore
Product recalled: Encore Beef Selection in Gravy (Multipack), Encore Beef Selection in Gravy (Multipack), Encore Beef Steak with Potatoes in Gravy (Individual tin)
FSA Recall date: 07/18/2022

Source: food.gov.uk
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I would like to file a complaint. Please send me proper proceeders to this process. A BMW black convertible vehicle driven by a teenager continues to speed probably 50-60 miles an hour constantly on Burlington Dr. Speed limit is 15 MPH in this subdivision. This individual speeds... See More around car parked etc This is a serious safety issue on the street. He is not the only problem, but a major problem which needs to be stopped. See Less
266


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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458


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.

The recalled product is:
- Propofol Injectable Emulsion, USP 100 mL Single Patient Use Glass Fliptop Vial, NDC: Vial: 0409-4699-54 Carton: 0409-4699-24, Lot Number: DX9067, Expiration Date Presentation: 01 MAY 2023, Configuration/Count: 1 g/100 mL, Single Patient Use Glass Fliptop Vial Case of 10 Units.

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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458


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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The Parks & Recreation Department has been testing the water at Cascade Lake and the bacteria levels were elevated. The specific bacteria that was showing elevation was E. Coli. Excessive rainfall, extreme heat in shallow bodies of water, which Cascade Lake is relatively shallow, and wildlife can... See More all be common causes for bacteria levels to increase. Parks & Recreation has voluntarily closed the beach until test results return to an acceptable level.

In case you are experiencing E. coli symptoms such as watery diarrhea (often bloody), vomiting; stomach cramps; and mild 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: rochestermn.gov
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