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Power Outage, Kailua, Hawaii, USA

July 13, 2021 10:47 PM

Kailua, Hawaii, United States

Crash into pole prompts power outage affecting approximately 1,120 customers were without power in the Kailua area.

Source: khon2.com

Reported By SafelyHQ.com User
More incidents from:
Power Outage
Kailua
Hawaii
United States

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“Company name: Teva Pharmaceuticals
Brand name: Teva
Product recalled: Topotecan Injection 4 mg/4 mL (1 mg/mL)
Reason of the recall: Presence of particulate matter
FDA Recall date: July 01, 2021
Recall details: Teva Pharmaceuticals has initiated a voluntary recall of lot 31328962B of Topotecan Injection 4 mg/4... See More mL (1 mg/mL), to the retail/institutional level in the United States. This voluntary recall was initiated based on a complaint received from a pharmacy after a single glass particle was observed inside one vial. After further examination of the complaint sample, two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.

The 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. While the health hazard risk could be severe if particulate matter is infused, Teva’s internal health assessment determined that the likelihood of patient exposure to impacted product is remote or unlikely.

To date, Teva has received no further complaints or reports of illness or injury.

- Carton NDC: 0703-4714. Vial NDC: 0703-4714-71. Lot# 31328962B. Exp. Date: 04/2022

Topotecan Injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy and for patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. It is also indicated for treatment of patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin. It is packaged in 4 mg/4 mL single use vials. The affected product information is listed in the table above. Teva distributed the product nationwide to six of its Wholesale customers.

Teva notified its customers on June 18th 2021 and asked that the lot be recalled and to make arrangements for impacted product to be returned. Any consumer who has questions or concerns should first consult with their health care provider(s).

Check the full recall details on fda.gov

Source: FDA
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July 1, 2021 8:00 PM

“Company name: Natural Instinct
Product recalled: Working Dog Duck, Pure Duck, Working Dog Puppy, Duck Carcass, Duck Necks
FSA Recall date: 07/01/2021
Recall details: Natural Instinct Ltd is recalling several dog food products containing duck because salmonella has been found in the products.

- Working Dog Duck... See More (1kg and 2x500g). Use by: 08 January 2022 15 January 2022 22 January 2022 13 February 2022 20 February 2022 11 March 2022 18 March 2022.
- Pure Duck (1kg and 2x500g). Use by: 08 January 2022 15 January 2022 22 January 2022 13 February 2022 20 February 2022 11 March 2022 18 March 2022.
- Working Dog Puppy (1kg and 2x500g). Use by: 15 January 2022 22 January 2022 13 February 2022 20 February 2022 11 March 2022.
- Duck Carcass (Pack of 2). Use by: 08 January 2022 15 January 2022 20 February 2022.
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(Pet owners) If you have bought any of the above products do not use them. Instead, return them to the store from where they were bought for a full refund. When handling and serving raw pet food it is always advised to clean utensils and feeding bowls thoroughly after use.

Consumers should wash hands thoroughly after handling raw pet food, bowls, utensils or after contact with the faeces of animals. Raw pet food should be stored separately from any food (especially ready to eat foods). Care should be taken when defrosting to avoid cross contamination of foods and surfaces.

In humans, symptoms caused by salmonella usually include fever, diarrhoea and abdominal cramps. Infected animals may not necessarily display signs of illness, but symptoms can include diarrhoea.

Check the full recall details on food.gov.uk

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July 11, 2021 10:50 AM

“Yeah I never received this item I would like my money back, Ordered off of Facebook got from yeahyard a miniature saw pruner
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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
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
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June 29, 2021 2:00 PM

“Company name: Manna Pro Products, LLC
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Manna Pro Products LLC was informed by the State of West Virginia of a positive Salmonella spp. result in a routine surveillance sample of Flock Party Quack Snacks.

Salmonella is a 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. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

The bags are magenta and light blue in color and made of plastic (see images below). These products have a Best By date of 12/2023, which is printed on the bottom of the bag. This voluntary recall applies only to Flock Party Quack Snacks with Best By dates of 12/2023.

Distribution of this product has been suspended while Manna Pro continues its investigation as to the source of the contamination. This product was distributed beginning February 2, 2021 at retail stores throughout the United States.

Customers who purchased Flock Party Quack Snacks with a Best By date of 12/2023 should stop feeding the product immediately, throw the product away, and contact Manna Pro at the phone number below for a full refund. Customers with questions or concerns should contact Manna Pro at (800) 690-9908 ext. 2, Monday through Friday from 8:00 AM to 4:00 PM Central time. Members of the media can should refer their inquiries to Noah Messel of O’Malley Hansen at (314) 656-8302 or Noah.Messel@omalleyhansen.com.  

Check the full recall details on fda.gov

Source: FDA
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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
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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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July 1, 2021 6:02 PM

“Company name: Ardil Commercial
Brand name: Limar
Product recalled: Hand sanitizer
Reason of the recall: Packaged in bottles that resemble drink containers
FDA Recall date: July 01, 2021
Recall details: Santo Domingo, Dominican Republic – Ardil Comercial is voluntarily recalling one lot of Limar Hand Sanitizer, packaged... See More in 4 oz bottles to the consumer level. The hand sanitizer is being recalled because it is packaged in containers that resemble water bottles.

The product poses a risk of ingestion. Ingesting hand sanitizer, which is intended for topical use, could potentially result in alcohol toxicity. Symptoms of alcohol toxicity may range from lack of coordination, slowed or slurred speech, drowsiness to coma, which can be fatal. Furthermore, ingesting alcohol can affect the brain and cause impaired driving or operating heavy machinery. Alcohol can also interact with numerous drugs which may result in serious adverse effects. Ingesting alcohol by people with alcohol addiction may interfere with maintaining abstinence. Additionally, people with alcohol addiction may seek large amounts of ethanol-based hand sanitizers as a substitute. 

To date, Ardil Comercial has not received any reports of adverse events related to this recall. The product is intended to be applied topically to help reduce bacteria on the skin that could cause diseases when soap and water are not available and is packaged in 4 oz bottles. under the brand Limar. The product can be identified by the bottle’s labels pictured below.  The affected product lots include the following lot number: 079932-4611-05-J with the following expiration date: May 2022. Hand Sanitizer 4 oz Limar was distributed nationwide to a distributor who may have further distributed nationwide in the USA.

Ardil Comercial is notifying its distributors and customers by telephone, press release and is arranging for a replacement of all recalled products. Consumers and distributors that have the product which is being recalled should return 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.

Check the full recall details on fda.gov

Source: FDA
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