A full-service outsourcing facility has issued a voluntary nationwide recall on 65 unused sterile drug products, which may turn out to be not as sterile as they should be.
FUSION IV Pharmaceuticals, doing business as AXIA Pharmaceutical says they’re issuing this recall to include all sterile products “out of an abundance of caution” after those products were found to be inconsistent with federal guidelines.
So far, no adverse events have been reported to the US Food and Drug Administration (FDA).
Included in the list of injectable drug products are dexamethasone, the corticosteroid often prescribed for a number of inflammatory disorders, and several dosages of erectile dysfunction drug, alprostadil.
Outsourcing facilities produce large batches of drug products and provide them to healthcare facilities as to drive down costs for the consumer. These drugs can be sterile or non-sterile compounded drugs, and are often a combination of two or more drugs tailored to the needs of an individual patient. While compounded drugs themselves are not necessarily FDA-approved, outsourcing facilities like AXIA (which fall under section 503b of the Federal Food, Drug and Cosmetics Act) are required to comply with current Good Manufacturing Practices and abide by other regulations.
Efforts to prioritize the safety of compounded drugs partly stemmed from the nationwide fungal meningitis outbreak of 2012. The outbreak was traced back to contaminated lots of methylprednisolone acetate (MPA) manufactured by the New England Compounding Center. The Centers for Disease and Control Prevention (CDC) reported 64 deaths out of the 753 patients afflicted with the disease. Prosecutors learned that pharmacist Glenn Chin failed to ensure the sterility of the drug products, even directing the compounding of drugs with expired ingredients.
A 2018 draft guidance outlines the agency’s attempt to clarify and introduce new regulations to ensure the safety and quality of compounded drugs. Because the drugs compounded at an outsourcing facility are not necessarily FDA-approved and inspections are only conducted on a risk-based schedule, concerns over drug safety remain high.
Drug safety continues to be an issue today. In 2019, the FDA issued nearly 200 inspection reports (Form 483) to compounding facilities, many resulting in serious warning letters.
One such warning letter was issued to Imprimis NJOF, LLC, a New Jersey-based compounding pharmacy for ophthalmic drugs. The company was hit with a long list of violations including compounding a drug that was not approved under section 503b, failing to submit adverse events reports and misbranding drugs.
For now, AXIA is urging customers to return recalled products for their safety. This is AXIA’s first run-in with the FDA, but due to lack of oversight, the safety of drugs produced at outsourcing facilities may not be guaranteed.