Massive Recall due to Rodent and Bird Feces

The U.S. Food and Drug Administration determined that the facility was operating under insanitary conditions, including the presence of rodent excreta, rodent urine, and bird droppings in areas where medical devices, drugs, human food, pet food, and cosmetic products were held.

Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release because of the presence of rodent and avian contamination.

Persons handling or consuming the products could become seriously ill due to adulteration from pests, including rodents, birds and insects. The U.S. Food and Drug Administration (FDA) determined that the facility was operating under insanitary conditions, including the presence of rodent excreta, rodent urine, and bird droppings in areas where medical devices, drugs, human food, pet food, and cosmetic products were held. These conditions create a significant risk that products held at the facility may have been contaminated with filth and harmful microorganisms.

Products held under insanitary conditions may become contaminated through contact with contaminated surfaces or exposure to airborne particulates associated with animal waste. Exposure to contaminated products can pose serious health risks to consumers, including the potential for bacterial contamination, which may result in illness or infection, including Salmonella. There are numerous hazards associated with rodents including the potential presence of Salmonella. Use or consumption of affected products may present risk of illness due to the potential presence of Salmonella, an organism which can cause serious and sometimes fatal infections in infants, young children, frail or elderly people, pregnant persons, persons with pre-existent pathology (e.g., patients with cancer undergoing chemotherapy treatments, organ transplant recipient, etc.) and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.

Additionally, products contaminated with filth, rodent excreta, and rodent urine may cause illness in the animals that consume the food or humans that are in contact with the products. Rodents are the main reservoirs of Leptospira the bacteria that causes leptospirosis in humans and animals.

Contaminated medical devices may increase the risk of device-associated infections, drugs and foods may cause adverse health effects if ingested, and cosmetics applied to the skin or eyes may lead to skin irritation, infection, or other adverse reactions.

The recalled products were distributed to some or all of the following stores:

Products covered by this recall include all: drugs; medical devices; cosmetics; dietary supplements; and human and animal (pet) food products. The recall does not apply to products shipped directly to retail/convenience stores by the distributor or manufacturer, such as all frozen and refrigerated items. For a comprehensive list of affected products, please visit the FDA website at fda.gov.

No illnesses have been reported to date.

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