Wednesday, April 27, 2022

 

 

Tuesday, April 26, 2022

 

FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy

FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections.

APS Pharmacy, located in Palm Harbor, Florida, which compounds drugs intended for human use and drugs intended for animal (veterinary) use, initiated the voluntary nationwide recall via a recall letter dated March 15, 2022. The company has sent recall letters to all patients and animal owners who received the recalled drugs, and they are contacting all customers via telephone calls and emails as part of their recall strategy.

The recalled drugs include “gonadorelin acetate,” “testosterone cypionate in grapeseed oil,” “testosterone cypionate/anastrozole in grapeseed oil,” “testosterone cypionate/DHEA in grapeseed oil,” and “testosterone cypionate/propionate in sesame seed oil” for human use, and “cyclosporin” and “tacrolimus” for animal ophthalmic use. These products were compounded between December 21, 2021, and March 7, 2022. The recalled drugs, lot numbers, and do-not-use beyond date - the date when the compounded drug should no longer be used - are listed here.

Read More Button

Friday, April 22, 2022

 

3 days ago — Background: Unregulated use of a variety of drugs and supplements by bodybuilders and athletes is common and can lead to severe adverse complications.

 

4 days ago — Like CBD and hemp products for humans, pet products are being sold to treat everything from anxiety to itchy skin and can make similarly outlandish claims.

 

11 hours ago — Many Teens Using Unregulated Supplements to Alter Appearance. Unregulated products can harm health, U.S. pediatricians' group warns. teen flexing

GOP megadonor doctor charged....

 

  1. 1 day ago · April 21, 2022, 12:39 PM Bob Daemmrich for The Texas Tribune Dr. Steven Hotze hired more than a dozen private investigators to look for election fraud in Harris County in 2020.

  1. 7 hours ago · Texas Doc Charged in Incident Related to Fabricated Voter Fraud — Steven Hotze, MD, was indicted this week on felony charges of assault and unlawful restraint by Jennifer Henderson, Enterprise &...

  2. 1 day ago · U.S. news Texas conservative activist charged after contractor accused of assaulting repairman over voter fraud claims Dr. Steven Hotze was indicted after a former police officer he

 Tuesday, as part of the FDA’s effort to protect consumers,  the agency issued a warning letter to Kleenhanz, LLC for selling unapproved products with unproven COVID-19 claims. Consumers concerned about COVID-19 should consult with their health care provider

 

  • Thursday, the FDA announced the availability of a draft guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine. The draft guidance, when finalized, will explain the agency’s intent to exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing products that are labeled as dietary supplements. This enforcement discretion policy would apply to products that would be lawfully marketed dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DOJ charges 21 defendants with COVID-related healthcare fraud schemes totaling $149M By Dave MuoioApr 21, 2022 12:36pm

https://www.fiercehealthcare.com/regulatory/doj-charges-21-defendants-covid-related-healthcare-fraud-schemes-totaling-149m

Thursday, April 21, 2022

FDA warns consumers not to purchase or use Artri and Ortiga products, which may contain hidden drug ingredients

https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-artri-and-ortiga-products-which-may-contain-hidden-drug 

 

Supervisor at Long Island Drug Manufacturer Sentenced to Prison for Theft of Medical Products

Drugs for Equine Illness Sold to Trainers and Veterinarians at New York Racetracks

On April 20, 2022, in federal court in Central Islip, Gregory Settino, a resident of Bethpage, New York, was sentenced by United States District Judge Joanna Seybert to a year and a day’s imprisonment for theft of approximately $750,000 worth of medical products. The Court also ordered Settino to pay restitution of $847,093.

Breon Peace, United States Attorney for the Eastern District of New York, and Ronne G. Malham, Acting Special Agent-in-Charge, Food and Drug Administration, Office of Criminal Investigations, New York Field Office (FDA-OCI), announced the sentence.

“Today’s sentence is the finish line of Gregory Settino’s criminal conduct. He stole thousands of bottles of drugs, ignored safe handling practices, and allowed them to be given to horses at New York racetracks without regard for the health of the animals – only focusing on his own personal gain,” stated United States Attorney Peace. “Those who jeopardize drug safety and risk the health of others will be held accountable and face serious consequences.”

Read More Button

Scientific-Integrity Watchdog Slaps Lawsuit on Maker of Homeopathic Pills — "It's time for Boiron and all homeopathy hucksters to be held accountable," says CFI attorney by Amanda D'Ambrosio, Enterprise & Investigative Writer, MedPage Today April 18, 2022

https://www.medpagetoday.com/special-reports/exclusives/98267?xid=nl_medpageexclusive_2022-04-21&eun=g649657d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=MPTExclusives_042122&utm_term=NL_Gen_Int_Medpage_Exclusives_Active 

Ohio Doctor Not Guilty of Murdering Patients With High Opioid Doses — Jurors, once at an impasse, found William Husel, DO, not guilty after a week of deliberations by Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage Today April 20, 2022 Last Updated April 21, 202

https://www.medpagetoday.com/special-reports/exclusives/98311?xid=nl_medpageexclusive_2022-04-21&eun=g649657d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=MPTExclusives_042122&utm_term=NL_Gen_Int_Medpage_Exclusives_Active 

Wednesday, April 20, 2022