FDA Issues Warning to Veterinary Drug Manufacturer - MedWaste Management FDA Issues Warning to Veterinary Drug Manufacturer - MedWaste Management

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FDA warning letter Linessa sheep medication coccidia

FDA Issues Warning to Veterinary Drug Manufacturer

The FDA has issued a warning letter to veterinary drug manufacturer Linessa Farms, LLC. A website review found that they sell products, namely the Blackout Five Pure Toltrazuril Powder and Blackout Five 5% Toltrazuril Solution, to treat or cure coccidia without FDA approval. The manufacturer has failed to meet the requirements for offering a new animal drug to the public.

The FDA is allowing the manufacturer 15 days to develop, implement, and report on their corrective plan. If the company fails to do so, the FDA may pursue legal action and recall the drug.  

SUMMARY

Date of Notice:

Announced: June 11, 2024

Name(s) of Drug:

Blackout Five Pure Toltrazuril Powder

Blackout Five 5% Toltrazuril Solution

Company Name:

Linessa Farms, LLC

Drug Indication:

Coccidia in animals

FDA warning letter Linessa sheep medication coccidia

About the Products

The drugs named above were offered for sale to the general public via https://linessafarms.com/ from December 2023 to May 2024. They were marketed for the treatment of coccidia in animals, namely sheep.

Reason for Warning Notice

All new drugs, whether for human or animal consumption, must be proven safe and effective to the FDA and approved for use prior to sale. The manufacturer failed to follow the FDA requirements for the approval of a new animal drug. Therefore, it is not currently approved for sale to the general public.

Warning Impacts

Animals who ingest the listed medications listed in the warning are at risk of unknown adverse effects as the FDA does not yet have adequate information from the manufacturer on the drug’s efficacy or safety.

The FDA is not issuing a drug recall at this time, but consumers should monitor Med Waste Management for future drug recalls related to the investigation.

Consumers

  1. The FDA has not issued a recall for these medications at this time, and there is no need for further action. If you have concerns regarding medication usage, contact your animal’s veterinarian directly.  
  2. If you use any medications from this company when caring for your animals, monitor their health for any adverse symptoms and notify your veterinarian if any concerns are noted.
  3. If your animals are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your veterinarian immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  4. If your veterinarian advises you to dispose of the medication, contact MedWaste Management for information and assistance with disposal.

Retailer

  1. Track drug recalls through the FDA or Med Waste Management websites.
  2. Notify affected consumers if a recall is announced.
  3. Contact MedWaste Management for information and assistance with disposing of medications if necessary.

Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal for the healthcare industry and the general public. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

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Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug and alcohol, and hospice and palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!

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