FDA Alert: Cease Immediate Use of Sterile Drug Products from Ranier's Compounding Laboratory Due to Lack of Sterility Assurance

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients not to use drug products intended to be sterile that are produced and distributed by Ranier’s Compounding Laboratory, also doing business as Ranier’s Pharmacy and Ranier’s RX Laboratory, Jeannette, Pennsylvania, due to lack of sterility assurance.

Healthcare professionals should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

The FDA issued a warning letter to Ranier’s Compounding in March 2017 following an inspection. During FDA’s recent follow-up inspection of Ranier’s compounding facility, investigators observed insanitary conditions, including poor sterile production practices, which raised concerns about the company’s ability to assure the sterility of its drug products.

On June 6, 2018, FDA recommended that Ranier’s Compounding recall all unexpired drug products intended to be sterile and to cease sterile operations until it makes adequate corrections at its facility. 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.

To date, FDA is not aware of any adverse events associated with the use of products from Ranier’s Compounding. Patients who have received drug products produced by Ranier’s Compounding and have concerns should contact their healthcare professional.

The FDA encourages healthcare professionals and patients to report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program by:

If you have additional questions, please contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.