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bio aaa Hand Sanitizer - recalled due to Potential Undeclared Methanol Contamination, USA

3 years ago

United States

Company name: AAA Cosmetica, S.A. de C.V.
Brand name: bio aaa
Product recalled: Hand Sanitizer
Reason of the recall: Potential Undeclared Methanol Contamination
FDA Recall date: July 14, 2020
Recall details: AAA Cosmética, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). To date, AAA Cosmética has not received any complaints or adverse event reports related to this recall.

The product is used as a hand sanitizer and it is packaged in 480 mL plastic bottles. The product can be identified by the label below. Product was distributed Nationwide in the United States. AAA Cosmetica is recalling the following bio aaa Advance Hand Sanitizer lots, all of which bear the expiration date of April 2022:

20DF9001 / 20DF9002 / 20DF9003 / 20DF9004 / 20DF9005 / 20DF9006
20DF9007 / 20DF9008 / 20DF9009 / 20DF9010 / 20DF9011 / 20DF9012
20DF9013 / 20DF9014 / 20DF9015 / 20DF9016 / 20DF9017 / 20DF9018
20DF9019 / 20DF9020 / 20DF9021 / 20DF9022

Risk Statement: Substantial methanol exposure could result in nausea, diarrhea, vomiting, severe abdominal pain, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Persons using these products on their hands may be at risk; however young children who accidently ingest them and adolescents and adults who drink these products are most at risk for methanol poisoning.

Check the full recall details on fda.gov

Source: FDA

303


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Pyramid Wholesale is issuing a recall of various brands of products sold as dietary supplements for sexual enhancement because they contain undeclared prescription drugs including Sildenafil (Viagra) and/or Tadalafil (Cialis). There have been no reports of injury or illness, to date. They were sold in bulk to... See More other distributors and retailers in California and out of state.

These products have the potential to cause severe adverse health effects due to misuse, overuse, interaction with other medications, underlying health conditions, and overall lack of oversight or consultation with medical professionals.

The products were distributed under 11 different brand names and varied in product form and size. A full list is available in the link below. Consumers should immediately discontinue use of the product.

Company name: Pyramid Wholesale
Brand name: Various
Product recalled: Dietary supplements for sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: March 20, 2024

Source: fda.gov
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288


Several brands of folic acid tablets have been recalled in Canada due to concerns that affected lots may exceed the acceptable intake limit for N-nitroso-folic acid. The recall involves multiple brands distributed across the country.

-Affected products
Brand: Compliments FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG,... See More Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHH
Brand: Equate FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115LRJ & 2G3115NHF
Brand: Health One FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NJL
Brand: Nature's Bounty FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2340T8130A
Brand: Pharmasave FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115NHG
Brand: Sisu FOLIC ACID 1MG, Product Name: FOLIC ACID 1MG, Market Authorization: NPN 00647039, Dosage Form: Tablet, Strength: Folate 1.0 mg, Lot numbers: 2G3115M1C

Consumers are advised to consult their healthcare provider if they have any health concerns related to this recall.

Return affected product to your local pharmacy or place of purchase. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.

If you or a loved one are harmed or experiencing any symptoms, it is important to report it. Reporting can help to detect & resolve outbreaks early and prevent others from being harmed, and enables better surveillance. If symptoms persist, seek medical care.

Source: recalls-rappels.canada.ca
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84


Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product... See More solution. The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022. To date, Par has not received any reports of adverse events related to this recall.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs, or brain which can cause stroke and even lead to death.

Treprostinil Injection is formulated for subcutaneous or intravenous infusion. The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require a transition from epoprostenol to reduce the rate of clinical deterioration.

Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only Lot 57014, expiration date 04/2024 is affected by this recall. Vials from the affected lot bear the attached label.

Par is providing written notification to wholesale accounts and the hospital location that has received the affected lot and is arranging for the return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue the use and stop distribution immediately.

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.

In case you experience 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. If symptoms persist, seek medical care.

Company name: Endo International, Par Pharmaceutical
Brand name: Par Pharmaceutical
Product recalled: Treprostinil 20mg/20mL Injection
Reason for the recall: Potential Presence of Silicone Particulate Matter
FDA Recall date: March 12, 2024

Source: fda.gov
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303


Brassica Pharma Pvt. Ltd. is voluntarily recalling the Eye Ointment products listed below with expiration dates ranging from February 2024 to September 2025. The products are being recalled due to a lack of sterility assurance. These products were distributed nationwide to wholesalers, retailers, and via the product... See More distributors, Walmart, CVS, and AACE Pharmaceuticals Inc. To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.

For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile. Ophthalmic drug products pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.

The affected products are:
- Product Name: Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols), Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: Equate, NDC: 79903-026-35, UPC Code: 681131395298.
- Product Name: Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil), Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: Equate, NDC: 79903-028-35, UPC Code: 681131395304.
- Product Name: CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil, Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: CVS Health, NDC: 76168-707-35, UPC Code: 050428634141.
- Product Name: Lubricant PM Ointment, Package Description: 3.5-gram tube, packaged in a cardboard box, Brand Name: AACE Pharmaceuticals, NDC: 71406-124-35, UPC Code: 371406124356.
For Lot number and expiry dates, you can visit the link below.

Brassica Pharma Pvt. Ltd. Is notifying its distributors AACE Pharmaceuticals Inc and its retailers Walmart and CVS. These distributors shall be further notifying the wholesalers and retailers via mail of this recall and arranging for return of all impacted products listed above. Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled Eye Ointment and may return any of the above listed products to the place of purchase.

In case you experience 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. If symptoms persist, seek medical care.

Company name: Brassica Pharma Pvt. Ltd.
Brand name: Multiple brands
Product recalled: Eye ointment products
Reason of the recall: Due to Potential Lack of Sterility Assurance.
FDA Recall date: February 26, 2024

Source: fda.gov
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303


“Today The World” is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found the products to contain undeclared Tadalafil and Nortadalafil. Products were distributed online nationwide in the USA. To date, no... See More adverse events have been reported.

Tadalafil and Nortadalafil (structurally similar to Tadalafil) are active drug ingredients known for treatment of male erectile dysfunction. The presence of Tadalafil and Nortadalafil in Sustain capsules and Schwinnng capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Risk Statement: Consumption of products with undeclared tadalafil or nortadalafil 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 this product, adult males who use nitrates for cardiac conditions are most at risk.

These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged and coded as follows:
SUSTAIN: BTH: 230551 having EXP:12.05.2026, BTH: 230571 having EXP: 14.05.2026 SCHWINNNG Lot 2108 having EXP 10/2024.

The World is notifying its customers by this press announcement of this recall release and is arranging for return/replacement etc. of all recalled products. Consumers that have Sustain or Schwinnng which is being recalled should stop using and return if desired to Today The World. The Sustain and Schwinnng products must include the blister pack foil (with any pills remaining) containing all lot codes and receipt of proof of purchase, and your return address.

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.

In case you experienced harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Today the World
Brand name: Sustain, Schwinnng
Product recalled: Sustain and Schwinnng brand male enhancement capsules
Reason of the recall: Products contain undeclared Tadalafil and Nortadalafil
FDA Recall date: February 05, 2024

Source: fda.gov
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On March 1, 2024, Sleepnet Corporation initiated a worldwide recall for all CPAP and BIPAP masks with magnets due to potential interference with certain medical devices. When a magnet comes into close proximity to certain medical implants or metallic implants, it could interfere with the performance or... See More the position of the implant, potentially resulting in serious injury or death. Sleepnet has been distributing masks with magnets worldwide since 2006 and to date, there have been no Medical Device Reports associated with the Sleepnet masks with magnets.

Affected products are Mojo Full Face Vented Mask, Mojo Full Face Non‐Vented Mask, Mojo 2 Full Face Vented Mask, Mojo 2 Full Face Non‐ Vented Mask, Mojo 2 Full Face AAV Non‐Vented Mask, iQ 2 Nasal Mask, and Phantom 2 Nasal Mask. This is applicable to all lot/UDI numbers.

Sleepnet masks with magnets are safe when used in accordance with the newly updated Instructions for Use. Continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.

Sleepnet is adding a new contraindication and an updated warning to the Instructions for Use labeling of the affected products. This will be included in the labeling for all future production of these masks. The labeling will be updated to state the following:
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Do not use this mask if you or anyone (example: household members, bed partners, caregivers, etc.) in close physical contact with your mask has an active medical implant or metallic implant that will interact with magnets. Implant examples include, but are not limited to, pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, aneurysm clips, metallic stents, ocular implants, insulin/infusion pumps, cerebral spinal fluid (CSF) shunts, embolic coils, metallic splinter, implants to restore hearing or balance with implanted magnets (such as cochlear implants), flow disruption devices, contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, bone substitute device, magnetic metallic implants/electrodes/valves placed in upper limbs , torso, or higher, etc. If you have any questions regarding the implant, consult your physician or the manufacturer of your implant.

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Magnets are used in the mask and headgear clips with a field strength of 380mT. With the exception of the devices identified in the contraindication, ensure that the mask is kept at least 6 inches (approx. 16 cm) away from any other medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This applies to you or anyone in close physical contact with your mask.

If a patient, or anyone in close physical contact, has an active medical implant or metallic implant, they should contact their mask supplier to find a replacement mask that does not include magnets. If the patient is unsure whether or not they should use the mask, they should consult their physician or the manufacturer of their implant.

In case you experience 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. If symptoms persist, seek medical care.

Company name: Sleepnet Corporation
Brand name: Mojo, Mojo 2, iQ 2, Phantom 2
Product recalled: CPAP and BIPAP Masks with Magnets
Reason of the recall: Potential interference with certain medical implants
FDA Recall date: March 18, 2024

Source: fda.gov
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The originating email does not have malwarebytes. com, the phone number is incorrect, and I never purchased malwarebytes premium. The actual malwarebytes offering is called “plus” and not “premium”, and malwarebytes does not offer a 3 year plan option, only monthly, annually, and 2 year. Even if malwarebytes did offer a 3 year plan, the total would come out to roughly $297 and not $399, since the annual option is priced at 99.99 on Malwarebytes’s website.

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