Hikma extends recall of pain drug due to 'potential presence' of sedative, reports adverse event

After Hikma initiated a recall of one batch of acetaminophen injection earlier this month, the company is extending the nationwide recall to the consumer level.

The company started the recall (PDF) due to the “potential presence” of a bag labeled dexmedetomidine HCL injection inside packaging labeled for acetaminophen injection, a pain med. Dexmedetomidine is a sedative often used before or during surgery.

Accidental administration of dexmedetomidine instead of acetaminophen poses risks of “varying degrees” of sedation for patients, plus slowed breathing or heart rate, variable blood pressure and “potentially life-threatening outcomes,” Hikma warned in a release.

So far, the manufacturer has received one report of an adverse event.

The lot in question was manufactured in March and expires in September 2025. Hikma first asked its direct customers to remove the product from distribution on July 8 and is now extending the recall to the consumer level. The company requests that customers at medical facilities locate, remove and return the affected product.

Acetaminophen injection is used to manage mild to moderate pain, reduce fever and quell moderate to severe pain alongside adjunctive opioid analgesics in patients 2 and older. The recalled intravenous infusion is sold in a 100mL bag of 1,000mg strength per 100 mL (10mg/mL).

Meanwhile, London-based Hikma will soon have a new plant to develop, manufacture, pack and distribute its IV bag products after striking a deal worth up to $185 million with Xellia in June. The generic drugmaker will take on Xellia’s Cleveland-based facility and make processes upgrades within the next three years through an undisclosed investment.