News & Press: Patient Safety

Safety Alert: The FDA Finds Ranier’s Compounding Laboratory Products Lack Sterility Assurance

Thursday, July 12, 2018  
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SIS Patient Safety Alert 07/12/2018: The FDA Alerts Health Care Professionals, Patients, Veterinarians and Animal Owners Not to Use Sterile Drug Products From Ranier’s Compounding Laboratory

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. Neither SIS, nor the FDA endorse either the product or the company.

ISSUE: 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’s Compounding Laboratory, also doing business as Ranier’s Pharmacy and Ranier’s RX Laboratory, Jeannette, Pennsylvania, due to lack of sterility assurance.

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.

The FDA issued a warning letter to Ranier’s Compounding in March 2017 following an inspection. During the 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.

BACKGROUND: On June 6, 2018, the FDA recommended that Ranier’s 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’s Pharmacy informed the FDA that it agreed to voluntarily recall and cease sterile operations. However, the company has failed to comply with its commitment.

RECOMMENDATION: To date, the 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 health care professional.

The FDA encourages health care 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:

  • Completing and submitting the report online; or
  • Downloading and completing the form, then submit it via fax at 1-800-FDA-0178.

For reporting animal adverse drug events, please see How to Report Animal Drug Side Effects and Product Problems.

Read the FDA MedWatch Safety Alert for further details.

Source: Food and Drug Administration - Accessed 07/12/2018


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