Medicine recalls
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| The United States: Amneal Pharmaceutical LLC issues a nationwide recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, due to the potential presence of particulate matter |
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The US Food and Drug Administration (FDA) announces that Amneal Pharmaceutical LLC is recalling 2 lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags (lot number: AL240003, AL240004) to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag.
The product is indicated for the production of local or regional anesthesia for surgery and or acute pain management. Introduction of polypropylene particulates into the epidural space (or inadvertent administration into the intrathecal space) may result in a variety of adverse events. There is a reasonable probability that particulate matter in the epidural space may cause an epidural inflammatory process to meningitis or potentially damage the spinal cord. Administered intrathecally, particulate matter could result in inflammation, hydrocephalus (water on the brain), which could lead to embolization and organ damage.
To date, Amneal Pharmaceuticals has received no reports of adverse events or injuries related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Apr 22, 2025
Issued at HKT 17:15
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