FDA issues warning on Jeannette company’s products

The U.S. Food and Drug Administration has issued an alert for patrons of a Westmoreland County compounding laboratory, warning not to use products labeled as sterile from Ranier’s Compounding Laboratory in Jeannette “due to a lack of sterility assurance.”

A compounding laboratory specializes in preparing medications — for human or animal use — that are not commercially available. Ranier’s Compounding Laboratory also does business as Ranier’s Pharmacy and Ranier’s RX Laboratory.

The FDA alert Tuesday says health care professionals and veterinarians should check their inventory, quarantine any Ranier products that are supposed to be sterile and not administer them to patients.

The alert did say that the FDA “is not aware of any adverse events associated with the use of products from Ranier’s Compounding” but noted that contamination of a product meant to be sterile “may result in serious and potentially lifethreatening infections or death.”

A phone request seeking comment from a Ranier official was not returned Tuesday afternoon.

The FDA release says it sent a March 2017 warning letter to Ranier after federal inspectors had found its sterile products “were prepared, packed, or held under unsanitary conditions.”

During a follow-up inspection two months ago, the FDA said, it again found “poor sterile production practices,” such as staff not changing gloves before working in a sterile processing area and not properly disinfecting pieces of equipment before placing them in the aseptic processing area.

On June 6, FDA officials recommended that Ranier halt sterile operations until it made corrections.

While Ranier agreed to the recall the following day, the FDA said Tuesday that the company “has failed to comply with its commitment.”