Medicine recalls
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| The United States: Hikma Pharmaceuticals USA Inc. extends voluntary nationwide recall of one lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) bags due to an individual unit of Acetaminophen overwrap found to have contained a labelled bag of Dexmedetomidine HCL Injection (400mcg/100mL) |
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The US Food and Drug Administration (FDA) announces that Hikma Pharmaceuticals USA, Inc., the subsidiary of Hikma Pharmaceuticals PLC (Hikma, Group), is extending its voluntary recall of one lot of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) (lot number: 24070381) 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).
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. To date, Hikma has received one report of an adverse event.
On July 8, 2024, Hikma voluntarily initiated a retail level recall of the product. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-one-lot-acetaminophen-injection
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Jul 23, 2024
Issued at HKT 16:00
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