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.
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.
Source:www.fda.gov
