Hikma Widens Pain Drug Recall Over Possible Sedative Contamination, Notes Adverse Event

Earlier this month, Hikma initiated a recall of a batch of acetaminophen injection due to the potential presence of a bag labeled dexmedetomidine HCL injection inside packaging meant for the pain medication. Dexmedetomidine is a sedative typically used before or during surgery. The risks associated with the accidental administration of dexmedetomidine instead of acetaminophen include varying levels of sedation, slowed breathing or heart rate, variable blood pressure, and potentially life-threatening outcomes. So far, there has been one reported adverse event related to this issue.

The lot in question was manufactured in March and is set to expire in September 2025. Initially, on July 8, the company requested its direct customers remove the product from distribution. The recall is now being extended to the consumer level, and Hikma is asking medical facilities to locate, remove, and return the affected product.

Acetaminophen injection is commonly used to manage mild to moderate pain, reduce fever, and alleviate moderate to severe pain when used in conjunction with opioid analgesics in patients aged 2 and older. The recalled product is an intravenous infusion sold in a 100mL bag containing 1,000mg of acetaminophen per 100mL (10mg/mL).

In other developments, Hikma, based in London, has secured a deal worth up to $185 million with Xellia to develop, manufacture, pack, and distribute its IV bag products. As part of this agreement, Hikma will take over Xellia’s facility in Cleveland and plans to make process upgrades within the next three years through an undisclosed investment.