Compounded Medications Recalled

Following a routine inspection of the pharmacy by the US Food and Drug Administration (FDA), Innoveix Pharmaceuticals Inc initiated voluntary recalls of the compounded drug products AOD-9604 3 mg and sermorelin/ipamorelin 3 mg. All lots of the drugs within expiry are included in the recall because of a lack of assurance of sterility, according to a July 13, 2021, Innoveix Pharmaceuticals announcement.

“Administration of a drug product intended to be sterile, that is not sterile, could result in serious infections which may be life-threatening,” the company stated. “To date, Innoveix Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.”

Included in the July 28, 2021, FDA Enforcement Report, the recall affects the following products, which were compounded by Innoveix, Addison, TX, and distributed throughout the United States to both customers and medical facilities:

• compounded lyophilized sermorelin/ipamorelin 3 mg, for subcutaneous or intramuscular injection, from lots SIP210 (Exp. 12/15/21), SIP215 (Exp. 1/14/22), and SIP220 (Exp. 1/23/22); and
• compounded lyophilized AOD-9604 3 mg, for subcutaneous or intramuscular injection, from lots AOD205 (Exp. 11/09/21), AOD210 (Exp. 11/18/21), AOD215 (Exp. 12/15/21), and, according to the FDA Enforcement Report, lot AOD220 (Exp. 1/20/22). The company announcement, however, lists the final recalled lot as AOD202 (Exp. 11/09/21).

Innoveix Pharmaceuticals initiated the recalls July 9, 2021. On July 20, 2021, the FDA designated them Class II, communicating use of the products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

According to the Innoveix announcement, the compounded products can be used for various indications as prescribed.