News & Press: Patient Safety

Safety Alert: Pharm D Solutions, LLC Voluntarily Recalling All Sterile Compounded Drugs

Tuesday, September 11, 2018  
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SIS Patient Safety Alert 09/11/2018: 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. Neither SIS nor the FDA endorse either the product or the company.

ISSUE: Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These 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.  These concerns arose following a routine inspection of the pharmacy by the FDA.

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. The pharmacy has not received any reports of patient complaints or adverse events related to this recall. To date, Pharm D Solutions, LLC is not aware of any adverse events related to this recall. Nor is there any indication that the compounded sterile drug products being recalled are actually contaminated. No medications or any component thereof have been shown to be non-sterile. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy’s highest priority.

BACKGROUND: The recall encompasses all compounded sterile drug products, within expiry, that were dispensed within the last twelve months. 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.

RECOMMENDATION: Consumers with questions regarding this recall can contact Pharm D Solutions, LLC by calling Luis R DeLeon or Carlos DeLeon at 713-790-1693, Monday through Friday between 9:00 a.m. and 5:00 p.m., CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

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.

Read the FDA MedWatch Safety Alert for further details.

Source: Food and Drug Administration - Accessed 09/11/2018


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