Pharm D Solutions issues nationwide recall of all sterile compounded drugs
The Food and Drug Administration on Friday said Houston, TX, Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the consumer level. FDA said the 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 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.
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.
