Wednesday, December 30, 2020

 

FDA In Brief: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin

The following quote is attributed to Amber McCoig, D.V.M., M.P.H., deputy director of the FDA’s Center for Veterinary Medicine (CVM) Division of Compliance:  


“Although this pet food recall is still unfolding, we are sharing the facts we have so far because the levels of aflatoxin found in the recalled pet food are potentially fatal. We are working quickly on this developing situation and will continue to update the public as new information becomes available. This is in service of FDA’s mission to protect human and animal health.”

Additional Information: 

  • The FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products manufactured by Midwestern Pet Foods, Inc. that may contain potentially fatal levels of aflatoxin.
  • The FDA is aware of at least 28 deaths and eight illnesses in dogs that ate the recalled product.
  • This is an ongoing investigation. Case counts and the scope of this pending recall may expand as new information becomes available.
  • Aflatoxin is a toxin produced by the mold Aspergillus flavus which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can...
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FDA Alert: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin

Fast Facts

  • FDA is alerting pet owners and veterinary professionals about certain Sportmix pet food products (see list below) manufactured by Midwestern Pet Foods, Inc. that may contain potentially fatal levels of aflatoxin.
  • FDA is aware of at least 28 deaths and 8 illnesses in dogs that ate the recalled product.
    This is an ongoing investigation. Case counts and the scope of this pending recall may expand as new information becomes available.
  • Aflatoxin is a toxin produced by the mold Aspergillus flavus, which can grow on corn and other grains used as ingredients in pet food. At high levels, aflatoxin can cause illness and death in pets.
  • Pets experiencing aflatoxin poisoning may have symptoms such as sluggishness, loss of appetite, vomiting, jaundice (yellowish tint to the eyes or gums due to liver damage), and/or diarrhea. In severe cases, this toxicity can be fatal. In some cases, pets may suffer liver damage but not show any symptoms.
  • Pet owners should stop feeding their pets the recalled products listed below and consult their veterinarian, especially if the pet is showing signs of illness. The pet owner should remove the food and make sure no other animals have access to the recalled product.
  • FDA is asking veterinarians who suspect aflatoxin poisoning in their patients to report the cases through the Safety Reporting Portal or by calling their local FDA Consumer Complaint Coordinators. Pet owners can also report suspected cases to the FDA.
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Tuesday, December 29, 2020

 

Wednesday, December 23, 2020

 

4 days ago — A Nicholasville, Ky., compounding pharmacy and its owner who have been linked to a sweep that saw nearly 30 federal indictments earlier this year, entered 

 

6 days ago — The California Veterinary Medical Board has proposed amending the California Code of Regulations to clarify the process for veterinarians to compound drug
6 days ago — 17, 2020 (HealthDay News) -- The number of U.S. drug overdose deaths ... deadly overdose -- compounded by possible co-infection with COVID-19 -- markedly 

 December 21, 2020; Department of Justice

Two Owners of New York Pharmacies Charged in a $30 Million COVID-19 Health Care Fraud and Money Laundering Case
The owners of over a dozen New York-area pharmacies were charged in an indictment unsealed today for their roles in a $30 million health care fraud and money laundering scheme, in which they exploited emergency codes and edits in the Medicare system that went into effect due to the COVID-19 pandemic in order to submit fraudulent claims for expensive cancer drugs that were never provided, ordered, or authorized by medical professionals.

 December 16, 2020; Department of Justice

Federal Court Orders North Carolina Pharmacy, Pharmacy Owner, and Pharmacist-in-Charge to Pay More Than $1 Million and Stop Dispensing Opioids
A federal court in the Eastern District of North Carolina entered a consent judgment and injunction requiring a North Carolina pharmacy, Seashore Drugs Inc., its owner, John D. Waggett, and its pharmacist-in-charge, Billy W. King II, to pay $1,050,000.00 in civil penalties and to cease dispensing opioids or other controlled substances, the Department of Justice announced
December 17, 2020; U.S. Attorney's Office, Western District of Washington
Bartell Drug chain settles allegations it filled invalid prescriptions: Pharmacy failed to have a system in place to ensure prescribers were licensed in Washington
Seattle - The U.S. Department of Justice and Bartell Drug Inc., today resolved allegations that, between July 2016 and August 2020, the pharmacy chain filled invalid prescriptions in violation of the Controlled Substances Act, announced U.S. Attorney Brian T. Moran. Under the terms of the settlement, Bartell Drug will pay the government an $800,000 fine. Bartell Drug fully cooperated in the investigation.

 

s_07504_12142020 HOUSE SUBSTITUTE FOR SENATE ...

4 days ago — controlled substance that is compounded for a drug shortage, as. 25 determined by the FDA. An out-of-state pharmacy shall comply with. 26 this part and the ...

 

NV Medicaid and NV Check Up Pharmacy Manual - Nevada ...

3 days ago — drugs for Medicaid recipients to be on tamper-resistant prescription pads. This requirement ... All compounded medications require prior authorization. Ref

 

INSPECTION GUIDE Terminal Distributor of Dangerous Drugs ...

3 days ago — (7) Placing dangerous drugs into containers prior to dispensing by a pharmacist. (8) Non-sterile drug compounding in accordance with the required tra
14 hours ago — Again, the agency cited the products for being unapproved new drugs that had ... to both types of compounding facilities about ensuring their compounded drug ...

 

Important Coronavirus information - waivers ... - Virginia.gov

6 days ago — The compounding pharmacy shall immediately notify the board if this allowance will be utilized. Nurses performing duties of pharmacy technician in opioid ...

 

 

 

FDA Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation and Mitigation Strategy Programs

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D.


While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.

To that end, the FDA has been and continues to address this public health crisis on a number of fronts, including efforts to:

  • Decrease unnecessary exposure to prescription opioids and prevent new addiction;
  • Support the treatment of those with opioid use disorder;
  • Foster the development of new and effective pain therapies; and
  • Take action against those who contribute to the illegal importation and sale of opioid products.

Part of our regulatory authority efforts include requiring Risk Evaluation and Mitigation Strategies (REMS) for various opioid analgesics to help mitigate the serious risks associated with their use.

Today, we took further steps to strengthen the REMS program for...

Thursday, December 17, 2020

 

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research


Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.

Additional Resources: