Amneal Pharmaceuticals LLC has issued a recall of two lots of its Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, due to potential particulate matter in the product. Specifically, the concern is over the presence of polypropylene fibers from the IV bag, which could enter the epidural space during medical procedures.
"Introduction of polypropylene particulates into the epidural space (or inadvertent administration into the intrathecal space) may result in a variety of adverse events," the company stated. Such incidents could potentially lead to severe health issues, including meningitis or spinal cord damage.
To date, no adverse events or injuries related to this recall have been reported, according to Amneal Pharmaceuticals. The affected product was distributed nationwide between April 23, 2024, and November 8, 2024. It is intended for local or regional anesthesia during surgery or for acute pain management.
The recall specifically involves lots AL240003 and AL240004, both with an expiration date of January 2026. Amneal is actively notifying customers and managing the return of the affected products. "We are arranging for the return of all recalled products," they explained, urging wholesalers and distributors to inform their own customers.
Healthcare facilities with questions about the recall can contact Amneal Pharmaceuticals via phone, fax, or email. Furthermore, any adverse reactions or quality issues related to the product should be reported to Amneal Drug Safety or through the FDA's MedWatch program.
"This recall is being conducted with the knowledge of the U.S. Food and Drug Administration," the company assured.
