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Don’t Use Sterile Drug Products From Pharm D Solutions, FDA Advises

Lack of Sterility Assurance Cited

Drug products intended to be sterile that are produced and distributed by Pharm D Solutions LLC, Texas, should not be used. Administering a non-sterile drug product that is intended to be sterile could result in serious and potentially life-threatening infections or death.

The FDA is advising health care professionals to immediately check their medical supplies, quarantine all purportedly sterile drug products, and not administer them to patients. Health care professionals should also take alternative steps to secure any medications they administer to patients from reliable sources that adhere to proper quality standards.

Patients who have received Pharm D drug products and who have concerns should contact their health care professional.

On September 10, 2018, following the FDA’s recommendation, Pharm D recalled all unexpired drug products intended to be sterile, and ceased sterile operations until adequate corrections had been made at its facility. However, the company resumed sterile operations on October 8 and distributed allegedly sterile products without having carried out the proper corrections. Pharm D agreed to stop sterile operations again on November 9, but to date has not complied with the FDA’s recommendation to recall all unexpired drug products that are intended to be sterile. These compounded drug products could put patients at risk.

Source: FDA.gov, November 20, 2018.

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