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Noble Crust, 8300 4th St N, St. Petersburg, FL 33702, USA
Total all time reports:
1
Latest report: June 22, 2020 12:00 PM
More incidents from:
Bar
Restaurant
Coronavirus - Covid-19
8300, 4th Street North
St. Petersburg
Florida
United States
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Recent Interesting Reports
July 19, 2021 3:02 PM
“Company name: Pfizer
Brand name: CHANTIX
Product recalled: Smoking cessation treatment
Reason of the recall: N-Nitroso Varenicline content above ADI level
FDA Recall date: July 19, 2021
Recall details: Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and... See More eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.
Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
Chantix is a treatment to help patients quit smoking and is intended for short term use. People who smoke cigarettes are 15 to 30 times more likely to get lung cancer than people who do not smoke. Smoking is also associated with many other cancers. CHANTIX has a safety profile that has been established over 15 years of marketing authorization and through a robust clinical program. Pfizer believes the benefit/risk profile of CHANTIX remains positive. Patients currently taking Chantix should consult with their doctor to confirm if they received an affected lot, and if appropriate, about alternative treatment options.
To date, Pfizer has not received any reports of adverse events that have been related to this recall.
The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from June 2019 to June 2021.
For more recall details including the NDC, Lot Number, Expiration Date, and Configuration details for Chantix Tablets check: fda.gov
Source: FDA See Less”
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1 era dosis Pfizer, Parque Bicentenario, Av. Río Amazonas, Quito, Ecuador
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I want my money back they scammed me, Chino Hills, CA, USA
Chino Hills, CA, USA
July 14, 2021 2:37 PM
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August 2, 2021 11:12 AM
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I was delivering a package Thursday I... See More was I'm going up a step and I slipped and fell on my right knee it is swollen and I'm not able to work as a result of a movie See Less”
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July 19, 2021 9:02 PM
“Company name: Alpha Male Plus
Brand name: Alpha Male Plus
Product recalled: Alpha Male Plus Male Enhancer fruit chew
Reason of the recall: Undeclared Tadalafil
FDA Recall date: July 19, 2021
Recall details: Tucson, AZ, Alpha Male Plus is voluntarily recalling all lots within expiry of Alpha... See More Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumers with underlying medical conditions who take Alpha Male Plus Male Enhancer 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, Alpha Male Plus has not received any reports of adverse events related to this recall.
The tainted Alpha Male Plus Male Enhancer product was manufactured by Dr Manuel Mascarenas M.D. in Tucson, Arizona located at 5190 E Farness Dr Ste 104, 85712. Dr Mascarenas is the originator and manufacturer of these products for the global market. Alpha Male Plus was selected to act as the US distributor and distribute these products for the US market.
The tadalafil ingredient was never disclosed or made known to its US distributor and was only discovered through FDA laboratory analysis. Dr Manuel Mascarenas is solely responsible for the creation, formulation and proliferation of this product. Through the use of concealment, dishonest means and an unknowing 3rd party Dr Mascarenas was able to begin distributing this mislabeled and potentially harmful product to the US market.
Alpha Male Plus was marketed as a dietary supplement for male sexual enhancement and is packaged in 1strip per foil pouch within a cardboard box, UPC [8 60003 03770 6] [8 60003 74512 0].
The affected Alpha Male Plus Male Enhancer includes all lots. The product was distributed nationwide in the USA via internet directly to consumers via their website.
Company is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using or return to place of purchase/discard/contact their doctor, etc.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
Source: FDA See Less”
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July 13, 2021 8:00 PM
“Company name: Innoveix Pharmaceuticals, Inc.
Brand name: Innoveix Pharmaceuticals, Inc.
Product recalled: Injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg
Reason of the recall: Potential lack of sterility assurance
FDA Recall date: July 13, 2021
Recall details: Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots... See More of sterile compounded drug products, within expiry. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.
Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening. To date, Innoveix Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.
The affected products are injectable Semorelin / Ipamorelin 3mg and injectable AOD-9604 3mg. The products can be used for various indications as prescribed. The products can be identified by an Innoveix Pharmaceuticals, Inc. label. The products were distributed in glass vials contained in a small 3 inch by 3 inch white box.
Products were distributed nationwide to both customers and/or medical facilities. A full list of the affected products with the applicable lot numbers and expiration dates is as follows:
Product Lot/Expiry
Semorelin / Ipamorelin 3mg Lot# SIP210; Exp: 12/15/2021
Lot# SIP215; Exp: 01/14/2022
Lot# SIP220; Exp: 01/23/2022
AOD-9604 3mg Lot# AOD205; Exp: 11/09/2021
Lot# AOD210; Exp: 11/18/2021
Lot# AOD 215; Exp: 12/15/2021
Lot# AOD202; Exp: 11/09/2021
Check the full recall details on fda.gov
Source: FDA See Less”
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Amphitrite Technology Limited, Purple Sage Lane, Hutto, TX, USA
Purple Sage Lane, Hutto, TX, USA
July 19, 2021 6:51 PM
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Dreambone twist dog treats Dog very sick after giving him two if these yesterday, Springdale, AR, USA
Symptoms: Other
Loss of Appetite
Vomiting
Springdale, AR, USA
July 7, 2021 11:46 AM
“Yesterday I bought and gave my dog two dream one twist dog treats. A couple hours later he was acting sick. Head down, not himself. He's a very energetic blue Lacy so this is unlike him. Yesterday evening I noticed he was trying to poo but couldn't.... See More He refused his normal treats (not the dream bone but he gets blue buffalo bits after potty breaks) this was another red flag . My boy never turns down a treat.
All last night he was restless. It's now 10 am on the day after giving him the dream bone twists. He's still restless, can't get comfy, lays down then stands up then sits down with his head down. Won't eat, even things he normally loves. I've rubbed his belly and tried to comfort him. I let him out and walked him around a bit to try and help his bowels move along. Still nothing. He ate a bit of grass which is normal when dogs don't feel good. A bit later he started puking a massive amount and I could see alot of undigested dream bone in it. Those dream bones are the only new thing hes had and now he's really sick. I'm scared after reading about other law suites and issues regarding this product that my dog might have obstructed bowels from eating eat. I'm watching him closely and ready to take him to the vet as soon as I see if he's going to improve after puking or not. Vet visits are really expensive and if he needs surgery or declines further I'm going to raise hell. It's not okay for money hungry corporates to line their pockets while falsely advertising its products as safe knowing dam well it's killing beloved animals. My dog deserved a treat not a fight for his life. See Less”
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July 23, 2021 12:03 AM
“Company name: HIS
Brand name: HIS
Product recalled: Dietary Supplement for Weight Loss
Reason of the recall: Undeclared Sibutramine
FDA Recall date: July 22, 2021
Recall details: Palisades Park, NJ, HIS is voluntarily recalling all lots and all presentations of Miss Slim (10 count & 30 count... See More capsules) to the consumer level. HIS decided to recall Miss Slim after it was contacted by the FDA regarding the presence of sibutramine in the product.
Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues. The presence of sibutramine in Miss Slim renders it an unapproved drug for which safety and efficacy has not been established and therefore subject to a recall. To date, HIS has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement and is packaged 10 count UPC (742137605030) and 30 count UPC (609728434472) capsules. The product sold online at missslimusa.com.
Risk Statement: Products containing sibutramine pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
HIS is notifying its customers by website missslimusa.com and is arranging for return of all recalled products. Consumers that have Miss Slim which is being recalled should stop using it. 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.
Check the full recall details on fda.gov
Source: FDA See Less”
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