FDA Announces Hikma Pharmaceuticals USA Inc.’s Voluntary Nationwide Recall of One Lot of Acetaminophen Injection, 1,000 mg/100 ml (10 mg/ml), Bags
On July 22, 2024, the U.S. Food and Drug Administration (FDA) reported that (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-one-lot-acetaminophen-injection) Hikma Pharmaceuticals USA, Inc., is extending its voluntary recall of one lot of acetaminophen injection, 1,000 mg/100 ml (10 mg/ml), to the consumer and user level. The product is being recalled because a bag labeled dexmedetomidine HCL injection (400 mcg/100 ml) may be inside an overwrap labeled as acetaminophen injection (1,000 mg/100 ml [10 mg/ml]).
If the healthcare professional does not identify the drug inside the acetaminophen overwrap as dexmedetomidine and administers the drug to a patient, Hikma said that (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-one-lot-acetaminophen-injection) multiple potential adverse outcomes may result, including varying degrees of sedation, bradypnea, bradycardia, hypertension, hypotension, and more serious and potentially life-threatening outcomes. To date, Hikma has received one report of an adverse event.
On July 8, 2024, Hikma voluntarily initiated a retail level recall of the affected lot, 24070381, which was manufactured on March 19, 2024:
| NDC | Size | Lot Number | Expiration Date |
|---|---|---|---|
| 0143-9386-10 0143-9386-01, Individual bag overwrap | 100 ml bag | 24070381 | Sep-2025 |
The product can be identified by name and NDC and lot code, which are clearly printed on the product label overlap.
Hikma reported that the product was distributed to its direct customers nationwide. 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 Inmar Rx Solutions Inc., Hikma’s recall service provider. Hikma is now extending the recall to the consumer/user level and asking customers at medical-level facilities to locate, remove and return the recalled lot.
Consumers with questions regarding the recall can contact Inmar by phone at 877-890-0765 (Monday–Friday, 9 am–5 pm ET) or by email at rxrecalls@inmar.com (mailto:rxrecalls@inmar.com).
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.
Consumers or healthcare professionals who encounter any tdverse reactions or quality problems with the use of this product should report it to the FDA’s MedWatch Adverse Event Reporting program (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda).