FDA Warning Letter: Neogen's Hycoat Linked to 20 Horse Deaths, Contamination Found
NEOG has more than doubled off its 52-week low of $5.37.
Summary
The FDA sent Neogen a warning letter on Sept 23 alleging Hycoat was misbranded, mislabeled, and manufactured under insanitary conditions. The agency found the product contaminated with multiple fungi, causing serious joint infections in about 100 horses and at least 20 deaths. Neogen had voluntarily recalled Hycoat in January, but this formal regulatory action escalates the matter and could lead to further enforcement. The company has 15 days to respond with corrective actions. This follows a year of product recall liabilities noted in the 10-K, and the warning letter adds regulatory risk to an already challenged animal health segment. The FDA also issued a warning letter to Sciarra Aeromed for fungal contamination in sterile veterinary wound product. Neogen shares fell 4.85% to $13.06 on Tuesday following the FDA warning letter. The warning letter was issued to Mike Nassif, president and CEO of Neogen Corp. The product is Neogen Vet’s HYCOAT (Hyaluronate Sodium Sterile Solution). The incident represents the largest number of equine fatalities ever associated with a product quality defect in any sterile FDA-regulated veterinary medical product. Federal investigators evaluated more than 95 individual clinical cases. FDA lab testing confirmed contamination in HYCOAT lot 5A001. The contaminated product caused tissue necrosis, surgical wound dehiscence, systemic sepsis, and euthanasia. Insanitary conditions included inadequate cleaning lacking sporicidal agents, unmonitored cleanroom air, absent sampling, and unsterile employee gowning. The cleanroom suffered structural disrepair, lacked differential pressure monitoring and airflow smoke studies. Regulators classified HYCOAT as adulterated under the Federal Food, Drug and Cosmetic Act. Labeling lacked warnings for off-label joint injections and directions for laypersons managing complex medical conditions. Packaging omitted language restricting product administration strictly to licensed veterinarians. Voluntary recall of HYCOAT lots 4L001, 4L002, and 5A001 occurred on Jan. 28. The cleanroom was constructed inside a warehouse facility.
Updated with a Benzinga report · What changed
Updates
· Benzinga — Neogen shares fell 4.85% to $13.06 on Tuesday following the FDA warning letter.
- Contamination and Clinical Impact
- The incident represents the largest number of equine fatalities ever associated with a product quality defect in any sterile FDA-regulated veterinary medical product.
- Federal investigators evaluated more than 95 individual clinical cases.
- FDA lab testing confirmed contamination in HYCOAT lot 5A001.
- The contaminated product caused tissue necrosis, surgical wound dehiscence, systemic sepsis, and euthanasia.
- Insanitary Conditions — Insanitary conditions included inadequate cleaning lacking sporicidal agents, unmonitored cleanroom air, absent sampling, and unsterile employee gowning. The cleanroom suffered structural disrepair, lacked differential pressure monitoring and airflow smoke studies, and was constructed inside a warehouse facility.
- Regulatory Classification — Regulators classified HYCOAT as adulterated under the Federal Food, Drug and Cosmetic Act.
- Labeling and Packaging — Labeling lacked warnings for off-label joint injections and directions for laypersons managing complex medical conditions. Packaging omitted language restricting product administration strictly to licensed veterinarians.
- Recall — Voluntary recall of HYCOAT lots 4L001, 4L002, and 5A001 occurred on Jan. 28.
All 13 details
- The warning letter was issued to Mike Nassif, president and CEO of Neogen Corp.
- The product is Neogen Vet’s HYCOAT (Hyaluronate Sodium Sterile Solution).
- The incident represents the largest number of equine fatalities ever associated with a product quality defect in any sterile FDA-regulated veterinary medical product.
- Federal investigators evaluated more than 95 individual clinical cases.
- FDA lab testing confirmed contamination in HYCOAT lot 5A001.
- The contaminated product caused tissue necrosis, surgical wound dehiscence, systemic sepsis, and euthanasia.
- Insanitary conditions included inadequate cleaning lacking sporicidal agents, unmonitored cleanroom air, absent sampling, and unsterile employee gowning.
- The cleanroom suffered structural disrepair, lacked differential pressure monitoring and airflow smoke studies.
- Regulators classified HYCOAT as adulterated under the Federal Food, Drug and Cosmetic Act.
- Labeling lacked warnings for off-label joint injections and directions for laypersons managing complex medical conditions.
- Packaging omitted language restricting product administration strictly to licensed veterinarians.
- Voluntary recall of HYCOAT lots 4L001, 4L002, and 5A001 occurred on Jan. 28.
- The cleanroom was constructed inside a warehouse facility.
- Contamination and Clinical Impact
At the time of this announcement, NEOG was trading at $13.46 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.9B. The 52-week trading range was $5.37 to $14.26. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: Seeking Alpha.