Innoveix Pharmaceuticals, Inc. is voluntarily recalling the following lots of sterile compounded drug products, within expiry, announced the U.S. Food and Drug Administration (FDA).
The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.
Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening. To date, Innoveix Pharmaceuticals, Inc. has not received any reports of 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 affected products are injectable Semorelin/Ipamorelin 3mg and injectable AOD-9604 3mg. The products can be used for various indications as prescribed. The products can be identified by an Innoveix Pharmaceuticals, Inc. label. The products were distributed in glass vials contained in a small 3-inch by 3-inch white box. Products were distributed nationwide to both customers and/or medical facilities.