LONDON (dpa-AFX) - UK-based Hikma Pharmaceuticals PLC announced that its unit Hikma Pharmaceuticals USA, Inc. is extending recall of one lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) bags to the consumer/user level.
The product is being recalled due to the potential presence of a bag labelled Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).
On July 8, Hikma had initiated a retail level recall of Acetaminophen Injection 1000mg/100mL(10mg/mL), lot 24070381.
The recall involves Hikma brand Acetaminophen Injection USP, 1,000 mg per 100 mL (10 mg/mL) in 100 mL bag with lot number 24070381 and expiration date of Sep-2025.
The lot being recalled was manufactured on 3/19/2024, and the impacted product was distributed to Hikma's direct customers nationwide.
Acetaminophen Injection is a sterile, nonpyrogenic ready-to-use solution, available in IV bags for intravenous infusion. Each 100 mL contains 1,000 mg acetaminophen, USP, 193 mg anhydrous citric acid, USP, sodium chloride, USP (tonicity agent) and water for injection.
The injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older, the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older and the reduction of fever in adult and pediatric patients.
The company noted that if the provider does not identify the drug inside the acetaminophen overwrap as dexmedetomidine and administers the drug to a patient, there are multiple potential adverse outcomes. This may result in varying degrees of sedation, bradypnea, bradycardia, hypertension, and hypotension or more serious and potentially life-threatening outcomes.
To date, Hikma has received one report of an adverse event related to the recalled product.
Hikma's direct customers are urged to locate and remove the recalled product from distribution channels and return to recall service provider -Inmar Rx Solutions Inc.
The company is now extending the recall to the consumer/user level, asking customers at medical level facilities to locate and remove the recalled product from their channels and return the recalled lot.
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