{"id":7770,"date":"2018-07-12T09:21:15","date_gmt":"2018-07-12T15:21:15","guid":{"rendered":"https:\/\/www.ebarrelracing.com\/articles\/?p=7770"},"modified":"2018-07-12T09:21:15","modified_gmt":"2018-07-12T15:21:15","slug":"fda-do-not-use-sterile-products-from-raniers","status":"publish","type":"post","link":"https:\/\/www.ebarrelracing.com\/articles\/watching\/fda-do-not-use-sterile-products-from-raniers\/","title":{"rendered":"FDA: Do not use sterile products from Ranier’s"},"content":{"rendered":"

[7\/10\/2018]<\/strong> The U.S. Food and Drug Administration is alerting health care professionals and patients, as well as veterinarians and animal owners, not to use human and animal drug products intended to be sterile that are produced and distributed by Ranier\u2019s Compounding Laboratory, also doing business as Ranier\u2019s Pharmacy and Ranier\u2019s RX Laboratory, Jeannette, Pennsylvania, due to lack of sterility assurance.<\/p>\n

Health care professionals and veterinarians 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.<\/p>\n

FDA issued a warning letter<\/a> to Ranier\u2019s Compounding in March 2017 following an inspection. During FDA\u2019s recent follow-up inspection<\/a> of Ranier\u2019s compounding facility, investigators observed insanitary conditions, including poor sterile production practices, which raised concerns about the company\u2019s ability to assure the sterility of its drug products.<\/p>\n

On June 6, 2018, FDA recommended that Ranier\u2019s Compounding recall all unexpired human and animal drug products intended to be sterile and to cease sterile operations until it makes adequate corrections at its facility. On June 7, 2018, Ranier\u2019s Pharmacy informed FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment.<\/p>\n

To date, FDA is not aware of any adverse events associated with the use of products from Ranier\u2019s Compounding. Patients who have received drug products produced by Ranier\u2019s Compounding and have concerns should contact their health care professional.<\/p>\n

FDA encourages health care professionals and patients to report adverse reactions or quality problems experienced with the use of these products to the FDA\u2019s MedWatch Adverse Event Reporting<\/a> program by:<\/p>\n