Acetaminophen Injection Recall Over Dexmedetomidine Mix-up

The UK-based Hikma Pharmaceuticals PLC has notified that Hikma Pharmaceuticals USA, Inc., a subsidiary, is expanding the recall of a single lot of bags containing acetaminophen injection, 1000 mg/100 mL and 10 mg/mL, to include consumers and users.

The reason for the product recall is that there may be a bag within the overwrap marked Acetaminophen Injection, 1000mg/100mL, (10mg/mL) that contains Dexmedetomidine HCL Injection (400mcg/100mL).A retail-level recall of Acetaminophen Injection 1000mg/100mL (10 mg/mL), lot 24070381, was started on 8 July by Hikma.The product in question is a 100 mL bag containing 1,000 mg of USP Hikma brand acetaminophen injection (10 mg/mL), lot number 24070381, and expiration date of September 2025.

The product under recall was sold to Hikma's direct clients across the country and was part of a lot that was made on March 19, 2024.For intravenous infusion, paracetamol injection is a sterile, nonpyrogenic, ready-to-use solution that comes in IV bags. 1,000 mg of USP acetaminophen, 193 mg of USP anhydrous citric acid, USP sodium chloride (tonicity agent) and water for injection are contained in each 100 mL.The injection can be used to reduce fever in both adult and paediatric patients as well as to manage mild to moderate pain in patients two years of age and older. It can also be used to treat moderate to severe pain in patients two years of age and older in conjunction with adjunctive opioid analgesics.

The manufacturer pointed out that there are several possible negative consequences if the healthcare professional gives a patient dexmedetomidine without realising it is contained in an acetaminophen overwrap. A range of sedative effects, bradypnea, bradycardia, hypertension, hypotension, and more severe, maybe fatal, consequences could arise from this.Hikma has only heard of one adverse occurrence connected to the recalled product thus far.Direct consumers of Hikma are asked to find the recalled product, take it out of distribution channels, and contact Inmar Rx Solutions Inc., the recall service provider, once again.

The business is now expanding the recall to include consumers and users, urging patrons of medical institutions to find the recalled product, take it out of their distribution networks, and return the recalled lot.