An FDA inspection of compound pharmacy Innoveix Pharmaceuticals indicated these lots may not be sterile.
Innoveix Pharmaceuticals, a compounding pharmacy in Addison, Tex., is voluntarily recalling several lots of compounded drug products. The products are being recalled due to a lack of assurance of sterility. The issues where discovered during a routine inspection by the FDA.
The affected products are injectable sermorelin/ipamorelin 3mg and injectable AOD-9604 3mg. Sermorelin and ipamorelin are human growth hormone secretagogues (GHSs), which are compounds that increase growth hormone release. AOD is a synthetic peptide thought to have potential for weight loss.
To date, Innoveix Pharmaceuticals has not received any reports of adverse events related to this recall.
Sermorelin / Ipamorelin 3mg
AOD-9604 3mg
Get the latest industry news, event updates, and more from Managed healthcare Executive.
PBM-Offered Genomics Testing Could Reshape Prescribing of Medications
July 25th 2025Two PBMs, True Rx Health Strategies and Capital Rx, are using pharmacogenomics — how a person’s DNA affects their response to medications — to reduce the trial-and-error of prescribing medications, saving employers and patients time and money.
Read More
FDA Extends Review of Blenrep Combinations in Multiple Myeloma
July 24th 2025Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.
Read More
Sarepta to Pause Shipments of the Gene Therapy Elevidys
July 22nd 2025Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.
Read More