TOPIC: Acetaminophen Injection, 1000 mg/100 mL Bags by Hikma Pharmaceuticals USA: Recall - Due to Individual Unit of Acetaminophen Overwrap Found to Have a Labelled Bag of Dexmedetomidine HCl Injection

AUDIENCE: Patient, Health Professional, Pharmacy, Pain Management, Pediatrics

ISSUE: Hikma Pharmaceuticals USA is extending its recall of one lot of Acetaminophen Injection, 1000 mg/100 mL, (10 mg/mL) due to the potential presence of a bag labelled Dexmedetomidine HCl Injection (400 mcg/100 mL) inside the overwrap that is labelled Acetaminophen Injection, 1000 mg/100 mL, (10 mg/mL).

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.

On July 8, 2024, Hikma voluntarily initiated a retail level recall of Acetaminophen Injection 1000 mg/100 mL (10 mg/mL), lot 24070381. The lot being recalled was manufactured on 3/19/2024.

To date, Hikma has received one report of an adverse event.

BACKGROUND: Acetaminophen Injection is a sterile, nonpyrogenic ready-to-use solution, available in IV bags for intravenous infusion. 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.

RECOMMENDATIONS:
1. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
2. Hikma notified its direct customers as part of the recall on July 8, 2024, asking them to locate and remove the recalled product from distribution channels and return the recalled lot to Hikma's recall service provider (Inmar Rx Solutions Inc.).
3. Hikma also requested the direct customers to notify their direct retail customers to whom this affected product lot was distributed. Hikma is now extending the recall to the consumer/user level and asking customers at medical level facilities to locate and remove the recalled product from their channels and return the recalled lot.
4. Consumers with questions regarding this recall can contact Inmar by telephone at 877-890-0765 or by email at [email protected].

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
1. Complete and submit the report online.
2. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Read the full recall.