FDA MedWatch - All Sterile Compounded Drug Products by Innoveix Pharmaceuticals:

Recall - Due to A Lack of Sterility Assurance

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: All Sterile Compounded Drug Products by Innoveix Pharmaceuticals: Recall - Due to A Lack of Sterility Assurance AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Innoveix Pharmaceuticals is recalling lots of sterile compounded drug products, within expiry due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority. Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threating. To date, Innoveix Pharmaceuticals has not received any reports of adverse events related to this recall.  For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The affected products are injectable Semorelin / Ipamorelin 3 mg and injectable AOD-9604 3 mg. The products can be used for various indications as prescribed.  RECOMMENDATIONS:  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 should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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