FDA News

FDA issues alert regarding Pharm D Solutions products

The FDA announced today, that due to a lack of sterility assurance, it is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions of Houston.

Pharm D provides injectable medications to clinics, clinical studies, hospitals, physicians and surgical centers, according to the company’s website.

“Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death,” the FDA’s announcement stated.

“Health care professionals should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Health care professionals should also make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards. ... Patients who have received drug products produced by Pharm D and have concerns should contact their health care professional,” the statement continued.

According to the FDA, it first issued a warning about Pharm D products after an inspection in December 2016. A follow-up inspection of Pharm D’s compounding facility in August 2018 revealed “insanitary conditions, including poor sterile production practices and deficient environmental monitoring.”

Injection 
The FDA announced today, that due to a lack of sterility assurance, it is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions of Houston.

Source:Shutterstock

The FDA stated that on Sept. 10, 2018, Pharm D followed the FDA’s recommendation and recalled all unexpired drug products intended to be sterile and was willing to cease sterile operations until it made “adequate corrections” at its facility. Pharm D, the FDA said, resumed sterile operations on Oct. 8 and distributed purportedly sterile products without making the corrections. Pharm D agreed to cease sterile operations again on Nov. 9, 2018 but has not agreed to FDA’s recommendation to recall all unexpired drug products intended to be sterile produced after Oct. 8 resumption of operations, according to the FDA.

PharmD had not responded to Healio Family Medicine’s request for comment before this story posted. 

The FDA announced today, that due to a lack of sterility assurance, it is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions of Houston.

Pharm D provides injectable medications to clinics, clinical studies, hospitals, physicians and surgical centers, according to the company’s website.

“Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death,” the FDA’s announcement stated.

“Health care professionals should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. Health care professionals should also make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards. ... Patients who have received drug products produced by Pharm D and have concerns should contact their health care professional,” the statement continued.

According to the FDA, it first issued a warning about Pharm D products after an inspection in December 2016. A follow-up inspection of Pharm D’s compounding facility in August 2018 revealed “insanitary conditions, including poor sterile production practices and deficient environmental monitoring.”

Injection 
The FDA announced today, that due to a lack of sterility assurance, it is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions of Houston.

Source:Shutterstock

The FDA stated that on Sept. 10, 2018, Pharm D followed the FDA’s recommendation and recalled all unexpired drug products intended to be sterile and was willing to cease sterile operations until it made “adequate corrections” at its facility. Pharm D, the FDA said, resumed sterile operations on Oct. 8 and distributed purportedly sterile products without making the corrections. Pharm D agreed to cease sterile operations again on Nov. 9, 2018 but has not agreed to FDA’s recommendation to recall all unexpired drug products intended to be sterile produced after Oct. 8 resumption of operations, according to the FDA.

PharmD had not responded to Healio Family Medicine’s request for comment before this story posted.