JFC. Wtf. “the products may contain an inert fiber identified as polypropylene fibers from the IV bag”. I’m sure it’s fine to put synthetic fibers in your veins. Total fine. 🤢

“FOR IMMEDIATE RELEASE – 04/18/2025 – Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of #Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag.
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.
To date, #Amneal Pharmaceuticals has received no reports of adverse events or injuries related to this recall.
The recalled product was distributed nationwide to wholesalers/distributors between the dates of 04/23/2024 to 11/8/2024 only.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp

#recall

Amneal Pharmaceutical LLC Issues a Nationwide Recall of Ropivacaine Hydrochloride Injection, USP 500mg/100mL, Due to the Potential Presence of Particulate Matter

Bridgewater, NJ, Amneal Pharmaceutical LLC, is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag.

U.S. Food and Drug Administration
"#Amneal said that the law, which was passed last year and took effect in January, was an illegal taking of its property under the #5thAmendment." #pharmaceuticals #EpiPen #prescriptions https://www.reuters.com/legal/government/amneal-asks-court-block-colorados-free-allergy-pen-program-2024-09-23/