Safety Report: Hikma Acetaminophen Injection - recalled due to Dexmedetomidine HCL presence, USA

United States

Hikma Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Acetaminophen Injection to the consumer/user level. The product is being recalled due to the potential presence of a bag labeled Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labeled Acetaminophen Injection, 1000mg/100mL, (10mg/mL). The product was distributed to Hikma’s direct customers nationwide. To date, Hikma has received one report of an adverse event.

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 that may result including varying degrees of sedation, bradypnea, bradycardia, hypertension, and hypotension or more serious and potentially life-threatening outcomes.

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. pH may be adjusted with hydrochloric acid and sodium hydroxide. Acetaminophen 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 affected lot number and expiration date being recalled are:
- Product Name and Strength: Hikma brand Acetaminophen Injection USP, 1,000 mg per 100 mL (10 mg/mL), Size: 100mL bag, Lot Number: 24070381, Expiration Date: Sep-2025, NDC: 0143-9386-10, 0143-9386-01, Individual bag overwrap.
The product can be identified by name, NDC, and lot code, which are clearly stated on the overwrap of the product label. The lot being recalled was manufactured on 3/19/2024.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Hikma Pharmaceuticals PLC
Brand name: Hikma
Product recalled: Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) 100 mL
Reason of the recall: Potential presence of Dexmedetomidine HCL Injection (400mcg/100mL) inside the overwrap that is labelled Acetaminophen Injection, 1000mg/100mL, (10mg/mL).

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-one-lot-acetaminophen-injection