Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Drugs
Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the 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 US Food and Drug Administration (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. To date, Pharm D Solutions, LLC is not aware of any adverse events related to this recall. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.
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. See the recall notice for a full listing of recalled product.
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.
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. 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.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program.
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