Hikma Pharmaceuticals USA Extends Recall of Acetaminophen Injection Lot

Hikma Pharmaceuticals PLC has announced that its U.S. subsidiary, Hikma Pharmaceuticals USA, Inc., is expanding its voluntary recall of one lot of Acetaminophen Injection, 1000mg/100mL (10mg/mL), to the consumer and user level. The recall is due to the possible presence of a bag labeled as Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap labeled as Acetaminophen Injection, 1000mg/100mL (10mg/mL). This discrepancy could lead to severe healthcare risks if the incorrect drug is administered.

Dexmedetomidine is a sedative, and if mistaken for acetaminophen, it can cause varying degrees of sedation, slow breathing (bradypnea), slow heart rate (bradycardia), and fluctuating blood pressure (hypertension or hypotension). These conditions can be life-threatening. As of now, Hikma has received one report of an adverse event related to this issue.

The initial recall was voluntarily initiated at the retail level on July 8, 2024, for the lot number 24070381, manufactured on March 19, 2024. Acetaminophen Injection is designed as a sterile, nonpyrogenic ready-to-use solution in IV bags for intravenous infusion. Each 100 mL bag contains 1,000 mg of acetaminophen, USP, along with other components like 193 mg of anhydrous citric acid, USP, sodium chloride, USP, and water for injection. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. This medication is used for managing mild to moderate pain in adults and pediatric patients aged 2 years and older, managing moderate to severe pain when used with opioid analgesics, and reducing fever in the same patient age group.

The affected lot can be identified by the name, NDC, and lot code on the product label, along with Hikma Pharmaceuticals USA Inc.'s name and address. The product was distributed nationwide to Hikma's direct customers, and the recall notice was issued to these customers on July 8, 2024. They were instructed to locate and remove the recalled products from their distribution channels and return the lot to Hikma's recall service provider, Inmar Rx Solutions Inc. Direct customers were also advised to notify their retail outlets that had received the affected lot.

Hikma is now extending this recall to the consumer and user level, urging medical facilities to identify and remove the recalled product from their channels. For any inquiries regarding the recall, consumers can contact Inmar by telephone or email. Additionally, any adverse reactions or quality issues experienced with this product should be reported to the FDA's MedWatch Adverse Event Reporting program.

Consumers who have used this product and are experiencing problems are advised to contact their physician or healthcare provider. This recall is being conducted with the awareness of the FDA.