TOPIC: Ropivacaine Hydrochloride Injection USP, 500 mg/100 mL by Amneal Pharmaceutical: Recall - Due to the Potential Presence of Particulate Matter
AUDIENCE: Patient, Health Care Professional, Pharmacy
ISSUE: Amneal Pharmaceutical is recalling two lots, Lot AL240003 and Lot AL240004, of Ropivacaine Hydrochloride Injection USP, 500 mg/100 mL, infusion bags because the products may contain an inert fiber identified as polypropylene fibers from the IV bag. No other Ropivacaine Hydrochloride Injection USP lots are impacted.
Risk Statement: 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.
The recalled product was distributed nationwide to wholesalers/distributors between the dates of 04/23/2024 to 11/8/2024 only.
To date, Amneal Pharmaceuticals has received no reports of adverse events or injuries related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is indicated for the production of local or regional anesthesia for surgery and or acute pain management.
RECOMMENDATIONS:
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Amneal is notifying its customers by UPS and is arranging for return of all recalled products.
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Wholesalers/distributors are asked to notify their hospital/user customers of the recall and provide instruction to contact Amneal for the return of the recalled products to Amneal.
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Hospitals/users with questions regarding this recall can contact Amneal Pharmaceuticals by: Phone: 833-582-0812; Fax: 631-983-2595 or E-mail to: RopivacaineHCl-Recall@amneal.com.
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For medical inquiries or to report adverse events, or quality problems experienced with the use of this product, please contact Amneal Drug Safety by phone at 1-877-835-5472.
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