Warning, recall, alert: Unsanitary lab conditions raise US FDA alarm

11-Jul-2018 - Last updated on 11-Jul-2018 at 14:35 GMT

(Image: Getty/Murat Göçmen)

An inspection of Ranier’s Compounding Laboratory has revealed poor sterile production practices, says the US FDA.

The US Food and Drug Administration (FDA) has alerted healthcare professionals, patients, veterinarians and animal owners against using and administering certain drug products from Ranier’s Compounding Laboratory in Jeannette, Pennsylvania.

According to the Agency, inspectors observed insanitary conditions, including poor sterile production practices, during a recent visit to the laboratory.

“Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death,” warned the FDA.

The alert follows an FDA warning letter issued to the firm in March 2017, and a subsequent request that Rainer’s Compounding recall all drug products intended to be sterile. The Agency also recommended the firm cease sterile operations until it addressed the concerns.

According to the FDA, “On June 7, 2018, Ranier’s Pharmacy informed FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment.”

Ranier’s Compounding Laboratory – which is associated with Ranier’s Pharmacy and Ranier’s RX Laboratory – did not respond to a request to comment ahead of publication.