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FDA Warns Against Use of Sterile Products From Medistat RX

Compounding pharmacy issues recall after inspectors find “significant deficiencies”

An Alabama compounding pharmacy recalled all nonexpired drugs produced for sterile use after inspectors found “significant deficiencies” and warned of possible contamination. The FDA has received reports of adverse events that are potentially associated with products made by Medistat RX, LLC, a 503B outsourcing facility.

The FDA alerted health care professionals and patients of the voluntary recall of products distributed nationwide by Medistat RX, based in Foley, Alabama, due to potential contamination. The pharmacy serves nine states, doing business with more than 5,000 prescribers and 25,000 patients. The recalled products were distributed between November 1, 2014, and September 3, 2015.

Contaminated drugs put patients at risk of serious infection. Health care professionals should immediately check their supplies, quarantine any drug products marketed as sterile from Medistat, and not administer them to patients. Administration of a nonsterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

During an ongoing inspection, FDA investigators and Alabama state inspectors found significant deficiencies that raise concerns about Medistat’s ability to assure the sterility of drug products that it produced. Medistat voluntarily ceased sterile compounding operations on September 1.

Patients who have received drug products produced by Medistat and have concerns should contact their health care professionals. 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:

The FDA is working closely with the Alabama Board of Pharmacy. The FDA previously inspected Medistat in September 2014 and issued an FDA Form 483 (which notifies a company’s management of objectionable conditions).

Medistat is registered under section 503B of the Federal Food, Drug, and Cosmetic Act as an outsourcing facility. The Drug Quality and Security Act of 2013 created section 503B, under which a compounder can elect to become an outsourcing facility. Outsourcing facilities:

  • Must comply with current good manufacturing practice requirements.
  • Will be subject to inspection by the FDA according to a risk-based schedule. 
  • Must meet certain other requirements, such as reporting adverse events and providing the FDA with certain information about the products they compound.

Sources: FDA; September 9, 2015; MediStat

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