Product Recall Due to Possible Pest Control Problems and Temperature Excursions at the Facility

Recommendation

4/5 October 2023

The GDP Compliance Manager - Live Online Training

The required storage conditions for medicinal products must always be met. If deviations occur, this can have an impact on the quality and, in the worst case, harm patients for whom the products are intended.

It is particularly problematic when deviations that can affect the quality of the products are discovered once the goods have already left the warehouse. This can then result in a recall, as a recently published example from the US shows. The case is about possible pest control problems and temperatures in excess of the storage condition instructions on the product labeling.

Company Announcement from 23 August 2023

On 23 August, a company announcement by Inmar Supply Chain Solutions, LLC was published on the FDA homepage. The company is voluntarily recalling a whole series of so-called FDA regulated products.

The products in question are not only drug products but also human food, animal food, and medical devices that were stored at the company's facility in Arlington, Texas, between 01 May 2022 and 30 June 2023. Due to the very long time period, many products are likely to be affected. According to Inmar Supply Chain Solutions, LLC, the products were sold to salvage buyers. All buyers have been notified and asked to destroy the goods.

What happened?

The company announcement states that the products were stored in a facility during a time when there may have been a pest control problem. In addition, because of recent unusually hot weather, it is possible that the goods may have been subjected to temperatures in excess of the storage condition instructions on the product labeling.

Risk Assessment

So far, the company has not received any customer complaints or reports of adverse events related to the described deviations. Based on the risk assessment, it was nevertheless decided to initiate the recall.

The risk assessment states that "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." But even in healthy adults, a salmonella infection can lead to fever, diarrhoea, nausea and vomiting.

With regard to the temperature variations, "products stored under temperatures in excess of storage conditions instructions in the product labeling could potentially lead to decreased product effectiveness."