Company Announcement Date: October 10, 2019
FDA Publish Date: October 10, 2019
Product Type: Drugs
Reason for Announcement: Potential lack of sterility assurance
Company Name: Innoveix Pharmaceuticals, Inc.
Brand Name: Innoveix Pharmaceuticals, Inc.
Product Description: Injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2
Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level. 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 Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2. The products can be used for various indications as prescribed. The products can be identified by an Innoveix Pharmaceuticals, Inc. label. Products were distributed to both customers and/or medical facilities. A full list of the affected products with the applicable lot numbers and expiration dates is as follows:
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 not use them and return the product to the pharmacy for a full refund.
Consumers with questions regarding this recall can contact Innoveix Pharmaceuticals, Inc. by phone 800-370-1910 or firstname.lastname@example.org. We are available Monday through Friday from 9 AM to 4:30 PM 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 this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.