XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.

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XTalks

MAY 18, 2023

Cornell University researchers have been making strides in the development of a revolutionary tool to combat dangerous pathogens in commercial dry food manufacturing plants. Recent incidents involving Cronobacter sakazakii infections linked to Abbott’s baby formula resulted in hospitalizations and tragic deaths, prompting product recalls.

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XTalks

SEPTEMBER 17, 2020

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., an Illinois-based processor of sprouts and soy products. Fortune Food Product did not respond to Xtalks’ request for comment.

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XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. According to AvKARE, the error occurred at a third-party bottle filling facility.

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Packaging Packaging Drugs Generic Pharmaceutical 52

STAT News

AUGUST 15, 2022

communities. Although researchers have known about the impact of these chemicals for years, there has been little guidance available for clinicians.

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XTalks

AUGUST 15, 2024

These tiny particles, primarily from environmental contamination, can infiltrate the food supply. In this episode of the Xtalks Food Podcast, Sydney talks about how microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised.

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Roots Analysis

FEBRUARY 28, 2022

Considering patient’s health and safety, the drug products are expected to be free from microbial contamination and should be safe for use throughout the drug’s life cycle. Therefore, several quality checks are performed to ensure product’s sterility and stability. Of these, majority of these are small sized companies.

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XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). While this act is intended to make it easier for consumers with food allergies to identify potential allergens in the products they purchase, many believe it falls short.

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XTalks

APRIL 11, 2024

As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations. Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination.

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XTalks

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants.

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The Pharma Data

DECEMBER 30, 2020

. “Although all persons using these products on their hands are at risk, young children who accidentally ingest these products, and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning ,” the FDA notice said.

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Pharma in Brief

AUGUST 9, 2021

The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties.

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FDA Law Blog

NOVEMBER 22, 2022

Some of us might still recall the 2017 salmonella outbreak linked to raw turkey products that caused over 279 infections, 107 hospitalizations, and one reported death in 41 states. coli contamination. When foodborne illness outbreaks arise, efficient traceability is critical to prevent illnesses, death, and unnecessary product loss.

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The Pharma Data

DECEMBER 30, 2020

. “Although all persons using these products on their hands are at risk, young children who accidentally ingest these products, and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning,” the FDA’s notice said.

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XTalks

OCTOBER 26, 2020

These days, it’s hard to find food, especially processed food, that isn’t encased in some form of packaging. Modern food packaging has allowed for safer, cleaner, more reliable, shelf-stable food – but at what cost? Discarded food, and the packaging it comes in, accounts for nearly 45 percent of waste in US landfills.

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Cloudbyz

AUGUST 19, 2024

Medical device safety is a multifaceted discipline encompassing the design, manufacturing, testing, and monitoring of devices throughout their lifecycle. Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market.

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The Pharma Data

NOVEMBER 4, 2020

” Type 2 Diabetes Drug Metformin Recalled Due to Contamination with Carcinogen. NDMA is an organic chemical used in the making of liquid rocket fuel and can be a byproduct of manufacturing, including pharmaceuticals. This is the latest in several recalls of metformin due to potentially cancer-causing contaminants, CNN noted.

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XTalks

AUGUST 10, 2020

The US Food and Drug Administration (FDA) announced a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. These chemicals help prevent grease and oil from seeping through the packaging. Why PFAS in Food Packaging Is a Problem.

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XTalks

FEBRUARY 5, 2021

There are a variety of materials that are used for food packaging, and they serve some very important functions in the food industry. Many of the foods purchased by consumers today are contained in packaging made from materials such as paper, plastic, metal or glass. One of the hallmarks of food packaging is the single-use design.

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pharmaphorum

NOVEMBER 24, 2022

Now, this service-centred model is delivering advantages in the pharmaceutical industry, with costly manufacturing facilities and processes becoming widely available on an on-demand basis. µm per cubic metre – with ISO 9 representing the least stringent measures, while still being significantly cleaner than typical manufacturing facilities.

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Pharmaceutical Technology

FEBRUARY 3, 2023

CAR T based therapies manufactured with lentiviral vectors are also on the rise, points out Clive Glover, PhD, General Manager, Pall Corporation. When you consider the existing challenges limiting the upstream production of viral vectors, this figure becomes even more alarming.

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XTalks

MAY 30, 2023

The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Behfar, senior scientist at VTT, in the news release.

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XTalks

FEBRUARY 8, 2024

In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing. The FDA rejected Biocon’s biosimilar in 2023 for the second time over manufacturing concerns at the company’s Malaysia facility and sent Biocon a complete response letter.

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Pharmaceutical Technology

DECEMBER 13, 2022

Freeze drying, also known as lyophilisation, is a common method of preservation used in many products, from the fresh herbs and vegetables that top store-bought pizzas to the instant coffee in our morning brew. Many pharmaceutical products are sensitive to heat, therefore the ability to dry contents at low temperatures is a clear advantage.

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Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. These syringes also have low risk in supply chain and streamlined regulatory process ( when compared to other materials ).

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Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard. Why do I write “exact same”?

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Pharmaceutical Technology

MAY 11, 2008

As a result, governments are eager to protect patients from counterfeit medication, save on the costs of fraud and introduce regulatory systems throughout the drug supply chain which can afford full accountability right back to the production facility. GS1 Ireland provided electronic barcoding technology for the scheme.

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Pharmaceutical Technology

MAY 2, 2023

The pharmaceutical industry is constantly striving for better, cleaner, safer manufacturing, especially when it comes to injectable medicines. Datwyler is a leading provider of parenteral packaging components and is helping the industry put quality first through the invention of the FirstLine® manufacturing standard.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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Pharmaceutical Technology

DECEMBER 8, 2022

smart manufacturing is a way of using advanced technology ecosystems to continuously improve product quality, drive savings, and meet demands. In the pharmaceutical industry, this modern approach to manufacturing is increasingly being seen as the best way to meet the high quality requirements demanded of the industry.

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Pharmaceutical Technology

JANUARY 12, 2023

– about the advantages and challenges of product lyophilization, developing lyophilization processes on site at their Bloomington, Indiana plant, and the importance of continuing research. That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded.

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Pharmaceutical Technology

JANUARY 6, 2023

Formulating products that have the proper composition, viscosity, texture, and stability, and can also be shown to be safe and effective, is both a science and an art. Without proper precautions, knowledge gaps can occur and important details may be overlooked when a product is transferred from one site to another. Simplicity matters.

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Pharmaceutical Technology

FEBRUARY 3, 2023

There are a number of reasons why OSD forms dominate the market, not least because they are simple to administer, and it is easy to differentiate one OSD product from another. Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated.

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FDA Law Blog

DECEMBER 14, 2023

Rescheduling cannabis to schedule III, the governors asserted, would protect the public against more dangerous drug use because legal cannabis products sold in states where they are legal “are significantly safer than myriad alternatives, including opioids.” Rightly or wrongly, the governors seem to be saying that with the U.S.’

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XTalks

SEPTEMBER 14, 2020

trillion) agreement reached in late July between leaders of the 27 countries in the European Union, a truly historic stimulus package designed to rescue flailing economies from COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. And stimulus packages continue.

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