Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag
Product details
- Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag
Company announcement
Amneal Pharmaceutical LLC is recalling two lots of Ropivacaine Hydrochloride Injection due to the potential presence of polypropylene fibers from the IV bag.
The recalled product was distributed nationwide between April 23, 2024 and November 8, 2024.
No adverse events or injuries have been reported to date.
Risk:
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.
Impacted states: Nationwide
Products:
- Ropivacaine Hydrochloride Injection, USP, 500mg/100mL
- Ropivacaine Hydrochloride Injection, USP, 500mg/100mL
Contact
For more information, call 1-877-835-5472.