FDA warns veterinarians against Ranier's Compounding Laboratory
Products cannot be guaranteed sterile; company has failed to issue voluntary recall.
The FDA has issued an alert for veterinarians and pet owners, as well as human healthcare professionals and patients, advising them not to use products produced and distributed by Ranier's Compounding Laboratory that are intended to be sterile. These products may not be sterile, the agency says in a public release.
Ranier's Compounding Laboratory, based in in Jeannette, Pennsylvania, also does business as Ranier's Pharmacy and Ranier's RX Laboratory.
In March 2017, the FDA issued a warning letter to Ranier's Compounding Laboratory after an inspection. During a recent follow-up inspection of the company's compounding facility, investigators found insanitary conditions, including poor sterile production practices, which raised concerns with investigators about the company's ability to assure the sterility of its products, the release states.
On June 6, 2018, the FDA recommended the company recall all unexpired animal and human drug products intended to be sterile and cease sterile operations until it makes corrections at its facility. The following day, June 7, Ranier's Compounding Laboratory informed the FDA that it would voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment to recall and cease operations, the release says.
As of July 10, the agency is urging veterinarians and other healthcare providers to check their medical supplies and quarantine any purportedly sterile drug products and cease administering them to patients. Administration of a nonsterile product that's intended to be sterile can lead to potentially life-threatening infections or death, it says.
To date, the FDA is not aware of adverse events associated with the use of products from Ranier's Compounding; however, the agency encourages veterinary professionals and pet owners to report adverse reactions or quality problems experienced with the use of these products by visiting this page and following the appropriate instructions.
Pet owners who have received products made by the company and have concerns should contact their veterinarian, the agency advises.