News & Press: Patient Safety

Pharm D Solutions Issues Recall of All Sterile Compounded Drugs

Friday, May 24, 2019  

SIS Patient Safety Alert 05/24/2019: Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Drugs Due to a Potential Lack of Sterility Assurance

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. In such cases neither SIS nor the FDA endorse either the product or the company.

On May 24, 2019, Pharm D Solutions, LLC issued a recall of all sterile compounded drug products within expiry to the consumer level. This recall is in follow up to a May 22, 2019 court order enjoining Pharm D Solutions to cease all sterile compounding operations and distribution until it completes corrective actions to ensure the company and its facility are in compliance with the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) FD&C Act.

Pharm D Solutions’ drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile.

Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death. To date, Pharm D Solutions, LLC is not aware of any adverse events related to this recall.

The recall encompasses all compounded sterile drug products, within expiry, that were dispensed within from October 24, 2018 to May 21,2019. The sterile drug products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The recall does not affect the pharmacy's non-sterile compounded products or retail pharmacy operations.

The pharmacy has notified potentially affected customers of the voluntary recall via U.S. Mail and direct outreach. Customers who have received sterile compounded products subject to the voluntary recall should stop using and return the product to the pharmacy for a full refund.

Click here for a list and photos of the recalled products.

Consumers with questions regarding this recall can contact Pharm D Solutions, LLC by calling Luis R DeLeon or Carlos DeLeon at 1-844-263-6846, Monday through Friday between 10:00 a.m. and 4:30 p.m., CST.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report online.
  • Regular Mail or Fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

SIS previously alerted interventional specialists about issues with this compounding lab on May 22, 2019, September 11, 2018, and November 20, 2018. Follow SIS on Facebook, Instagram, LinkedIn, and Twitter for information on important patient safety issues as they arise.

Source: Food and Drug Administration - Accessed 05/24/2019

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