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MKS Enterprise LLC Honey - recalled due to undeclared active pharmaceutical ingredient tadalafil, USA

2 months ago

United States

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 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

466


Related Reports

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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466


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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466


Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary... See More recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of abundance of caution.

-Recalled products:
Product Description: Clopidogrel 75mg Tablets, 1,000 Count Bottle, GSMS NDC: 51407-032-10, Lot #: GS046745, Expiration Date: 12/2023
Product Description: Atenolol 25mg Tablets, 1,000 Count Bottle, GSMS NDC: 60429-027-10, Lot #: GS046745, Expiration Date: 12/2023

Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems as indicated in the product labeling. For more drug label information about clopidogrel bisulfate visit: DailyMed - CLOPIDOGREL- clopidogrel bisulfate tablet, film coated (nih.gov). For more drug label information about atenolol visit: DailyMed - ATENOLOL tablet (nih.gov)

Patients who suddenly stop taking atenolol, as would happen if clopidogrel were misplaced in the atenolol-labeled bottle, are at increased risk for ischemic (angina, myocardial infarction), hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta antagonism. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen. To date, GSMS, Inc. has not received any reports of adverse events related to the use of the products as part of this recall.

The lot under GSMS, Inc.’s voluntary recall has been primarily sold to AmerisourceBergen, and McKesson. AmerisourceBergen and McKesson are instructed to immediately stop distribution, quarantine all remaining products in their control, and return the recalled product to GSMS, Inc. They are also instructed to provide their customers, i.e., pharmacies and consumers, a copy of GSMS, Inc.’s recall notification, recall response form, and letter to consumers, patients, and caregivers.

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: Golden State Medical Supply, Incorporated
Brand name: Golden State Medical Supply, Incorporated
Product recalled: Clopidogrel 75mg Tablets, Atenolol 25mg Tablets
Reason of the recall: Due to Label Mix-up
FDA Recall date: September 29, 2022

fda.gov
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466


The boil water advisory that was in effect in the City of Reidsville has been lifted as of 11:04 a.m. on Friday.

Source: twitter.com
Published: 2022-10-07 See Less


Beckley Water Company has issued a boil water advisory for the Midway Road, Monson Court, Pemberton Road, Carter Avenue, Blue Room Road, Hatfield Road, Valley View Road, Ballard Street, 1st Avenue, Roselawn Avenue, Brammer Avenue, and Broadway Avenue areas.

Source: twitter.com
Published: 2022-10-07 See Less


Springlake-Earth ISD has been put under a boil water notice, according to a school district representative.

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Lake View city officials announced this (Friday) morning that the boil order issued earlier this week for customers on the community’s water supply has been lifted.

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A power outage affecting more than 2,000 customers was reported in downtown Cape Girardeau shortly after 10 a.m. on Friday, October 7. the outage was caused by an equipment issue when a switch on the system failed.

Outage link: outagemap.ameren.com
Source: kfvs12.com
Published: 2022-10-07 See Less


Electric power was knocked out to parts of Logan early this morning (Friday, Oct. 7) when a large dump truck whose driver had neglected to lower the vehicle’s dump bed tore down traffic lights and utility lines above state Route 93/Mulberry Street at the intersection with Front... See More Street. Power was out to many nearby businesses as of around 9:30 a.m. Friday.

Outage link: outagemap.aepohio.com.s3.amazonaws.com
Source: logandaily.com
Published: 2022-10-07
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According to National Grid’s website by a little after 7 a.m., about 720 customers were without power in Watertown, with another 30 out in the town of Pamelia. According to reports, the outage was caused by a sparking transformer on a utility pole at 22270 U.S. Route... See More 11.

Outage link: outagemap.ny.nationalgridus.com
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Recent Interesting Reports

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


Although I received an empty package from 188 South Mountain house Parkway Tracy CA 95377 the 1st class postage says mailed from zip 90021 on September 24, 2022. See Less
3.1K


AN
a..........d
Sme empty package
Reply 1 week ago
UN
u.........d
Same empty package
Reply 6 days ago
PE
anonymous7155
Same here !! WTF !!!
Reply 6 days ago
MG
anonymous7159
Same empty package. What kind of scar is this?
Reply 6 days ago
CH
anonymous7160
received one today... same date , same package.
Reply 6 days ago
JS
j...s
I also got one. Same ship date, same empty envelope
Reply 5 days ago
IZ
i.........y
Me as well....
Reply 5 days ago
CM
c....6
I did also today, same story, did you by any chance order anything from on facebook? I did thats why I'm asking so I'm wondering if its connected to that
Reply 5 days ago
MP
m.........s
Same here as well
Reply 4 days ago
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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Original tracking sticker from China was covered by a new sticker showing Online Seller as where package shipped from. I ordered BOGO offer on a Cat wheel and received a linen doily. I should have known it was to good to be legitimate. Now a Chinese company... See More has my credit card information as well as my personal details. SCAM. See Less
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She began to have diarrhea 3 days ago after eating the first Dream bone. We didn't relate the problem. She got a second one the next day and the diarrhea continued for 3 days. Last night blood began to pour from her. Today they are trying to see where the bleeding is coming from to save her. | Symptoms: Diarrhea, Bloody Stool See Less
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A supplement called captain boss bully ruby 10000 made my eyes burn,water,skin burn, vomiting, shaking, goosebumps. One of the worst experiences of my life

I bought it at a convenience store witch was prob my first mistake. I’ve taken them before and never had any issues. It... See More was the only brand left so I have it a go 20 minutes later my fave and eyes started burning and my eyes got really red. I got home around 830 took a shower and no longer then 5 min started puking none stop. It’s been going on for 3 hrs. Dizzy, goosebumps and worst of all I’m not in the mood whatsoever now. | Symptoms: Vomiting, Shaking See Less
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My location is Connecticut, USA. Received a black plastic item of some kind from 188 South Mountain Parkway, Tracy CA which I never ordered.  I did order a large dog bed which tracking claimed was delivered on 9/19 but did not receive.  I believe I may have... See More received this instead but not …. Apparently got ripped off. See Less
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