FDA issues Class I recall on dangerous infusion bags

The U.S. Food and Drug Administration (FDA) and Amneal Pharmaceuticals have announced a recall on two lots of Ropivacaine Hydrochloride Injection infusion bags, due to polypropylene material coming loose in the fluid. 

Ropivacaine solutions are used as anaesthesia during surgeries, and particles entering the epidural space can cause severe inflammation at the infusion site. Further, the loose plastic fibers could enter the body through the IV, leading to serious infections, water on the brain, potential organ damage and death. 

While no injuries have been reported, this recall is designated a Class I, the most serious type. All hospitals and other users are advised to take notice. 

What is being recalled?

The recall is limited to Ropivacaine Hydrochloride Injection infusion bags (USP, 500mg/100mL), manufactured by Amneal. Further, the dangerous defect is limited to products distributed to wholesalers between April 2024 and November 2024. However, it is possible some still remain in supply. 

The bags are packaged as 12x100mL single dose IV bags.

• Product ID: NDC 70121-17343. 
• Lots: AL240003 and Lot AL240004, all with an expiration date of January 2026. 

Use of infusion bags affected by the recall must cease immediately. 

Next Steps

Amneal has attempted to notify known customers in a letter, which contains instructions for initiating a return.  Wholesale distributors have also been asked to notify hospitals of the dangers associated with the recalled lots. 

Anyone with questions can contact Amneal at 1-877-835-5472, between 8:00 a.m and 6:00 p.m. on weekdays.  Additionally, anyone in possession of the affected bags can email the company to initiate a return at [email protected].

If any user has knowledge of an averse event associated with this recall, they are asked to report it to FDA MedWatch.

The full notice from the FDA can be found here.