08/23/2022

08/16/2022

Tramadol US

Center for Drug Evaluation and Research | CDER

Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet

 Congressman's wife died after taking herbal remedy, coroner's report says

A coroner's report, obtained by Kaiser Health News, says Lori McClintock died​ from dehydration due to gastroenteritis caused by "adverse effects of white mulberry leaf ingestion."

Read in CBS News: https://apple.news/ACREJXvj2QxWZVuYP20KjbQ

Death of congressman’s wife linked to ‘white mulberry leaf ingestion’ – coroner Edwin Rios - 2h ago

https://www.msn.com/en-us/news/politics/death-of-congressman-s-wife-linked-to-white-mulberry-leaf-ingestion-coroner/ar-AA115F3K?ocid=msedgntp&cvid=02f7e82850c0653dcc2148634ec632fd 

 

• On Wednesday, the FDA updated its Letter to Health Care Providers - Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by Haiou. In June 2022, Guangdong Haiou Medical Apparatus Co., Ltd. initiated a voluntary recall of the HAIOU Needle Retractable Safety 1 mL syringe with 23G 1-inch needle and the HAIOU Needle Retractable Safety 1 mL syringe with 25G 1-inch needle for device failure.

 

1st Circ. Partially Resurrects Azurity's Beef With Edge Pharma

https://www.law360.com › articles

4 days ago — Compounded drugs are made by combining, mixing, diluting or altering a drug, according to the decision. And some compounded drugs aren't subject to certain 

 

Adopted Rules Title 22 - the Texas Secretary of State

https://www.sos.state.tx.us › archive › August192022

10 hours ago — The prescription drug and medication orders, written compounding procedure, preparation records, and expended materials used to make compounded non-sterile

Azurity lawsuit over compounding pharmacy's rival drug revived

 

Azurity lawsuit over compounding pharmacy's rival drug revived

https://www.reuters.com › legal › government › azurity-la...

4 days ago — A federal appeals court ruled that Azurity Pharmaceuticals Inc may pursue a claim that a drug-compounding company sold a "copy" of the drugmaker's ...

Walmart, Walgreens, and CVS Are Being Fined $650 Million—Here's Why Abby Reinhard - Yesterday 4:26 PM

https://www.msn.com/en-us/health/medical/walmart-walgreens-and-cvs-are-being-fined-650-million-here-s-why/ss-AA10OBQV?ocid=msedgntp&cvid=b5802d79c10940e2a46c02982f9addad#image=2 

 

08/16/2022	08/08/2022	Oregon’s Wild Harvest, Inc.	Division of Human and Animal Food Operations West VI	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
08/16/2022	03/30/2022	Verde Cosmetic Labs LLC	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
08/16/2022	08/10/2022	Cangene BioPharma, LLC dba Emergent BioSolutions	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated
08/16/2022	07/29/2022	Deggeh Foods, Inc.	Office of Human and Animal Food Operations East – Division 1	Unapproved New Drugs/Misbranded
08/16/2022	07/28/2022	EH Maldonado and Company	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)

 

FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies Agency Remains Committed to Protecting Youth by Enforcing Against Illegal Products Today, the U.S. Food and Drug Administration issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product. These types of gummies are of particular public concern because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children. The manufacturer, VPR Brands LP (doing business as, “Krave Nic”), markets gummies that have 1 milligram (mg) of nicotine each and are available in three flavors – Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain tobacco-free nicotine. This firm has not submitted a premarket tobacco product application (PMTA) to the FDA, and does not have a marketing authorization order to manufacture, sell or distribute these products in the U.S. “Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year,” said FDA Commissioner Robert M. Califf, M.D. “We want parents to be aware of these products and the potential for health consequences for children of all ages – including toxicity to young children and appeal of these addictive products to our youth. The FDA will not stand by as illegal products infiltrate the marketplace.” The manufacturer states that each gummy contains 1 milligram of nicotine with 12 gummies (12 mg) per tin. Research indicates that ingesting 1 to 4 milligrams of nicotine could be severely toxic to a child under 6 years of age depending on the child’s body weight. However, nicotine toxicity among youth of any age may lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. Nicotine is also highly addictive and exposure during adolescence can harm the developing brain. In a recent study published in the journal PediatricsExternal Link Disclaimer, researchers found that flavored non-tobacco oral nicotine products, including gummies and lozenges, were among the most commonly used tobacco product among youth in southern California – second only to e-cigarettes. Use was particularly high among certain racial or ethnic, sexual or gender minority groups, and those with a history of nicotine use. These flavored non-tobacco oral nicotine products present an increased risk to youth due to their resemblance to kid-friendly food or candy products, such as gummies or gum, the availability in youth-appealing flavors, and the ability for teenagers to conceal use from adults.  The warning letter issued today requests a written response from the manufacturer describing how the firm intends to address any violations and bring their products into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Failure to promptly correct violations can result in further action such as civil money penalties, seizure, and/or injunction. Additionally, the firm must not sell or distribute violative products. The firm must submit a PMTA and receive marketing authorization from FDA before selling or distributing the product in the U.S. In response to the increase of non-tobacco nicotine in tobacco products, including in some of the e-cigarette brands that are most popular with youth, Congress passed a federal law that went into effect on April 14, 2022, clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source. This law gives the FDA authority over products made with non-tobacco nicotine, including synthetic nicotine, and imposes requirements under the FD&C Act for manufacturers, importers, retailers and distributors of non-tobacco nicotine products. To date, no non-tobacco nicotine product has received a marketing granted order.  “We remain unwavering in our use of compliance and enforcement resources to curb all unlawful marketing of tobacco products, especially those that youth could easily confuse with something that they consume regularly – like candy,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Today’s action should be a wake-up call for manufacturers of these illegal products that the FDA is actively working to identify violations and to swiftly seek corrective actions.” Efforts such as these support the FDA’s commitment to using a science-based approach to protect youth from initiating tobacco use. In addition to the FDA’s regulatory oversight, the agency recognizes the critical need for targeted youth tobacco prevention efforts designed to protect America’s kids, including mass media campaigns such as “The Real Cost.” The FDA also collaborates with the Centers for Disease Control and Prevention on the National Youth Tobacco Survey, the only nationally representative survey of middle and high school students that focuses exclusively on tobacco product use.

 

08/05/2022

08/04/2022

FluxxLab LLC

Center for Drug Evaluation and Research | CDER

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

 

08/09/2022	07/22/2022	Muscle Feast, LLC	Office of Human and Animal Foods – East 5	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
08/09/2022	08/04/2022	Amazon.com, Inc.	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug
08/09/2022	08/04/2022	JB Exchange Inc./Justified Laboratories	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug
08/09/2022	08/04/2022	Ariella Naturals	Center for Drug Evaluation and Research | CDER	Finished Pharmaceuticals/Unapproved New Drug
08/09/2022	07/12/2022	Zyno Medical LLC	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated
08/09/2022	06/16/2022	InfuTronix LLC	Center for Devices and Radiological Health	CGMP/QSR/Medical Devices/Adulterated
08/09/2022	08/03/2022	Valley Biosystems	Center for Biologics Evaluation and Research (CBER)	Bioresearch Monitoring Program
08/09/2022	07/28/2022	Vitti Labs, LLC	Office of Biological Products Operations – Division 2	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

 

Regulatory Agenda - Federal Register

https://www.federalregister.gov › 2022/08/08 › regulat...

2 days ago — 95, Distribution of Compounded Drug Products Under Section 503A of the ... to the List of Bulk Drug Substances That Can Be Used To Compound Drug Products in ...

Agencies issue update on ethylene oxide risk from commercial sterilizers | AHA News

Agencies issue update on ethylene oxide risk from commercial sterilizers | AHA News: The Environmental Protection Agency released a list of commercial medical device sterilizing facilities where lifetime risk from ethylene oxide emissions are highest to people who live nearby.

 

08/02/2022	07/19/2022	DSP Skin Care LLC	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
08/02/2022	07/05/2022	Transworld International Trading Corp.	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)

 

08/05/2022

08/04/2022

FluxxLab LLC

Center for Drug Evaluation and Research | CDER

Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

 

North Carolina Woman Pleads Guilty to Selling Unapproved Covid-19 Remedies

CONCORD – Diana Daffin, 69, of Charlotte, North Carolina, pleaded guilty in federal court to selling unapproved drugs with the intent to defraud or mislead the FDA, United States Attorney Jane E. Young announced today.

According to court documents and statements made in court, Diana Daffin owned and operated a holistic medicine company called Savvy Holistic Health doing business as Holistic Healthy Pet. In March 2020, the Food and Drug Administration (FDA) learned that Daffin was selling unapproved drugs on her website, with the brand name HAMPL, that Daffin claimed were COVID-19 remedies and treatments. In April and August of 2020, the FDA sent Daffin warning letters explaining that various products she was selling—including the HAMPL COVID-19 drugs—were adulterated, misbranded, and unapproved drugs and that she should take immediate action to correct the violation. Daffin responded by telling the FDA that she removed the products from her website and would stop distributing them.

 

Illegal Pharmacy Operator Sentenced to Federal Prison

Distributed Hundreds of Thousands of Drugs Without Proper Prescription

A man who illegally sold thousands of doses of controlled substances and misbranded prescription drugs was sentenced today to 15 months in federal prison, fined and ordered to forfeit over $500,000 in drug proceeds.

Jon Stidham, age 57, from McClelland, Iowa, received the prison term after a January 5, 2022 guilty plea to one count of conspiracy to deliver, distribute or dispense methyltestosterone, a Schedule III controlled substance, by means of the Internet without a valid prescription and without complying with federal and Iowa licensing requirements, and one count of conspiracy to introduce misbranded drugs into interstate commerce with intent to defraud or mislead and to commit mail fraud.

In a plea agreement, Stidham admitted that he operated a business called Kennel Supply, LLC. Kennel Supply provided a variety of items used for the operation of kennels and the care of farm animals at a brick-and-mortar location. On the Internet, Kennel Supply sold controlled substances and non-controlled prescription drugs that require prescriptions to lawfully dispense to the ultimate user. From 2015 through October 12, 2018, Stidham distributed and sold over 300,000 doses of methyltestosterone, a controlled substance, without valid prescriptions, profiting $324,303. During that same time-period, Stidham illegally distributed over 50 types of misbranded prescription drugs without a valid prescription or authorization, and illegally profited $203,207.

 

FDA Approves the First Generic Firocoxib Tablets for Horses

The U.S. Food and Drug Administration has approved the first generic firocoxib tablets for pain and inflammation associated with osteoarthritis in horses.

Firocoxib Tablets for Horses contain the same active ingredient (firocoxib) in the same concentration and dosage form as the approved brand name drug product, Equioxx Tablets, which was first approved on July 24, 2016.

Firocoxib is a nonsteroidal anti-inflammatory drug (NSAID). Like many NSAIDs, firocoxib works by affecting certain enzymes that trigger pain, fever, and inflammation.

 

'Rogue' Online Pharmacies Are Dispensing Cancer Drugs