Gold Star Distribution, Inc., has issued an urgent recall of various FDA-regulated products across three states. This notice pertains to an array of items including drugs, medical devices, cosmetics, human food, and pet food. The decision follows a determination by the FDA citing the presence of rodent and avian contamination, which poses serious health risks to consumers and animals.
What prompted this recall?
The recall was triggered after FDA inspections revealed unsanitary conditions at a Gold Star facility located in Minneapolis. Evidence of rodent excreta, rodent urine, avian droppings, and other contaminants such as insects were found in areas storing regulated products. These contaminants can introduce harmful microorganisms, including Salmonella, which may put individuals and animals at risk of severe illness or infection.
What are the risks associated with these products?
Drugs: Contaminated drugs may cause adverse health reactions when consumed.
Medical Devices: Unsanitary conditions heighten the risk of device-associated infections.
Human Food: Adulteration by pests can lead to dangerous bacterial infections, including Salmonella and leptospirosis.
Pet Food: Animals consuming contaminated food may develop bacterial infections or other illnesses.
Cosmetics: Products applied to the skin or eyes may result in irritation, infection, or other harmful effects.
What products are affected?
The recall encompasses all FDA-regulated drugs, medical devices, cosmetics, dietary supplements, and human and pet food items distributed in the three states listed. However, some items, specifically frozen and refrigerated products directly shipped to retail and convenience stores, are excluded from the scope of this recall. A comprehensive list of recalled products is available on the FDA’s website.
Steps consumers should take
Consumers and retailers are advised to destroy any affected products immediately and provide proof of destruction to Gold Star at their Minneapolis address: 1000 N. Humboldt Ave, Minneapolis, MN 55411. Refunds can be requested from Gold Star Distribution following verification.
If any health concerns arise from using these products, individuals should contact their healthcare provider or physician promptly. Pet owners concerned about animals that consumed the recalled food items should consult their veterinarian.
How to report adverse events
The FDA has encouraged users to report any quality problems or adverse reactions tied to these products through its MedWatch Adverse Event Reporting program. Reports can be submitted online or via mail/fax by downloading the appropriate forms.
Additionally, facilities or individuals can report safety issues, including sanitation concerns, using the FDA’s SmartHub.
Summary and key actions
This recall highlights the importance of facilities adhering to strict sanitary guidelines to ensure product safety. Gold Star Distribution’s rapid response underscores its accountability in addressing contamination issues. Consumers must remain vigilant, destroy impacted products, and promptly seek medical or veterinary advice if concerns arise.
Disclaimer
This article is for informational purposes only and is not intended as legal or regulatory advice. Professionals should consult the FDA website and Gold Star Distribution for official guidelines.
For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gold-star-distribution-inc-issues-recall-certain-fda-regulated-products-three-states-including-drugs