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Prime Time Pub and Grill, 8177 Bell Oaks Dr, Newburgh, IN 47630, USA

Total all time reports:  1
Latest report: July 6, 2020 12:00 PM

Employee test positive for Covid-19

July 6, 2020 12:00 PM

“An employee at Prime Time Pub and Grill in Newburgh tested positive for COVID-19

Source: 14news.com See Less
Reported By SafelyHQ.com User

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Recent Interesting Reports

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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Sibutramine was an FDA-approved drug used as an appetite suppressant for weight loss but was withdrawn from the market because of safety issues.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
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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
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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
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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
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“Company name: Johnson& Johnson
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Recall details: Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA® and AVEENO® aerosol sunscreen... See More product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and follow the instructions set forth below.

The only sunscreen products impacted are aerosol products, specifically: NEUTROGENA® Beach Defense® aerosol sunscreen:
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- NEUTROGENA® Ultra Sheer® aerosol sunscreen
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Benzene is classified as a human carcinogen, a substance that could potentially cause cancer depending on the level and extent of exposure. Benzene is ubiquitous in the environment. Humans around the world have daily exposures indoors and outdoors from multiple sources. Benzene can be absorbed, to varying degrees, by inhalation, through the skin, and orally. Based on exposure modeling and the Environmental Protection Agency’s (EPA) framework, daily exposure to benzene in these aerosol sunscreen products at the levels detected in our testing would not be expected to cause adverse health consequences. Out of an abundance of caution, we are recalling all lots of these specific aerosol sunscreen products.

While benzene is not an ingredient in any of our sunscreen products, it was detected in some samples of the impacted aerosol sunscreen finished products. We are investigating the cause of this issue, which is limited to certain aerosol sunscreen products. Sunscreen use is critical to public health. Melanoma incidences continue to increase worldwide, and the majority of cases are caused by excessive sun exposure. It is important that people everywhere continue to take appropriate sun protection measures, including the continued use of alternative sunscreen.

The recalled sunscreen products are packaged in aerosol cans. The products were distributed nationwide through a variety of retail channels.

Consumers should stop using these specific products and appropriately discard them.

Check the full recall details on fda.gov

Source: FDA
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July 1, 2021 9:13 PM

“July 12, 2019 around 7:30pm, Tantrum, a Gerstlauer EuroFighter Roller Coaster, experienced a malfunction as a car embarked on the 90 degree vertical lift hill. The train came to a halt and despite multiple attempts by park personnel to clear faults and override system warnings from the... See More control system (each attempt advancing the car by one rollback click up the hill) riders had to be evacuated. Riders remained tightly restrained in the ride vehicles upwards of one hour and forty five minutes to two hours. In order to evacuate guests, a vertical lift attached to the ride base was brought up to the edge of the car.

A rear metal mesh panel was swung out from the lift across the back of the car to assist riders in the rear in the event of a mishap on exiting. From there, workers manually released rider restraints one at a time. Each rider then had to roll and/or climb over the individual bucket seats at a 90+ degree angle and maneuver around the lap bar and seat belt restraints while in a single gait belt style harness which was secured to the edge of the ride lift by a sturdy harness brace.

Rescue workers assisted the riders off the Rollercoaster one by one starting with the rear row of 4 going left to right across the cars, and ending with the front row of 4 in a left to right fashion. Once the first four riders were rescued the lift was lowered to let them disembark from the roller coaster before ascending to the top to retrieve the following four in the front car. At the exit of the ride, a worker took the names and numbers of involved guests and guests were given a water bottle and pass to skip the line of one ride of their choice.

The riders were stuck in a 90+ degree position (while the ride itself has a 90 degree lift hill in this section, the seats of the ride vehicles have additional pitching to increase the feeling of being upside down and suspended, resulting in further heightened pressure against the extremities and other section of the body by restraints in this position) for close to 1 hour and 45 minutes to 2 hours, with the last rider having exited the ride close to 9pm.

According to multiple guests, the first riders were not informed that medical attention was available if needed and may not have been seen by the guests as they exited the ride. One to two guests requested medical attention at the park's front guest services department. The riders were subjected to undue attitude and questioning, in addition to being verbally ridiculed by the guest services agents before the service agents offered to call for medical attention.

One guest was sent home from the park in a wheelchair due to blood flow issues in their legs from the restraints on the roller coaster pressing against them for an extended period while at a 90+ degree angle, resulting in cold extremity on one side of the body, pain, and decreased sensation in the extremities also documented and recognized by the attending medical aids.

According to multiple other riders, at least one guest requiring a cane with various disabilities was denied assistance by a loved one from the exit of the ride, as security had emptied the section of the park and refused to allow the loved one or to bring the assistive device from the rider's loved one to the ride exit to assist them. This resulted in additional emotional and physical suffering of the rider as they were then required to walk a fair distance without any aid until they reached the security guard who refused to offer assistance.

In addition, the checks completed by ride operators include ensuring restraints are as tight fitting as possible by pressing down firmly and forcefully on the restraints often advancing the position of the restraint further. Restraints of course, do not loosen unless released by operators at the completion of the ride. However, because the ride was not able to complete its circuit, this resulted in further adverse events and possibility of unknown future adverse events due to hidden damage below the skin surface following the incident.

It was noted by multiple guests that the park seemed to be "concerned more about their status as a six flags park again and preventing recording or viewing by guests to avoid potential bad publicity than it did for the guests on and exiting the ride once rescued and removed." According to multiple guests this was not the first time this ride had stopped unexpectedly within the last 24 to 48 hours and has been a consistent problem with the ride since opening.

It should further be considered extremely important, dangerous, negligent, and reckless of maintenance workers to continue to advance the train despite ride safety system faults preventing the ride from advancing further. These attempts to further advance the coaster are in direct conflict to the manufacturer safety mechanisms put in place following incidents at a fellow Gerstlauer roller coaster, The Smiler at Alton Towers, England.

These systems were put into place following catastrophic occurrences in which limbs were lost and human life was endangered when maintenance operators overrode the ride's block system sending a car of guests careening into a stalled car further down the line. These overrides were specifically addressed by subsequent maintenance work and system upgrades by Gerstlauer, not just on The Smiler, but for all of their roller coaster models. Attempts to override this system are unconscionable.

Update as of July 1, 2021:
Following FOIA requests that were backed up due to COVID-19, I have been informed by the Attorney General's office that the park failed to report this incident to the inspecting body of NYS. There are no records when there certainly should be.

This is highly important as the very system that was attempted to be overridden was put into place to prevent catastrophic accidents from ocurring for a multitude of reasons. At The Smiler before this system had a safe guard added, mechanics were able to override the fault which lead to a major accident that resulted in the physical crushing, and resulting need of removal of limbs from guests
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Reported By SafelyHQ.com User

July 13, 2021 4:17 PM

“I ordered the Battery-Powered Wood Cutter, this is the second one I’ve ordered and have not received I either want my money back for 2 or I want them sent. On April 15th they shipped a Battery Powered WOOD CUTERR, I have not received it yet, plus... See More I ordered one before this, I would like to know where they are,  Aphitrite Technology limited See Less
Reported By SafelyHQ.com User