Particulate contamination has sparked the recalls of numerous injectable drugs over the years, with Amneal’s hospital med ropivacaine now the latest to fall victim to the trend.
Amneal is recalling two lots of ropivacaine hydrocholoride injection on the risk that the anesthetic could contain inert “fibers” that leeched into the product from its IV bag, according to a notice on the FDA’s website.
The recall, which covers a 500-mg/100-ml dose of the drug packaged in infusion bags, is specifically concerned with particulate contamination by the common thermoplastic polymer polypropylene.
Patients could suffer serious side effects if the contaminated drug is delivered epidurally or inadvertently administered to the intrathecal space via the spinal canal, Amneal warned in its recall notice.
The company cautioned of a “reasonable probability” that particulate matter in the epidural space could damage the spinal cord or set off an epidural inflammatory process to meningitis. When administered intrathecally, the particulates in the tainted drug also have the potential to cause inflammation and water on the brain, which can lead to embolization and organ damage.
As of Friday, Amneal had not received any side effect or injury reports tied to the suspect drug batch.
Ropivacaine is used as both regional anesthesia for surgery and as a tool for acute pain management in hospitals.
Amneal’s product pull covers hospital meds shipped across the U.S. between April and November last year.
Amneal triggered a separate recall last March when it pulled four batches of the antibacterial oral solution vancomycin hydrochloride, which is used to treat intestine and colon inflammation. At the time, the company noted that it may have “overfilled” certain bottles during a manual portion of the manufacturing process.
That error could have led to patients receiving more of the medication than intended, putting them at risk of worsening kidney function, Amneal warned at the time.
Particulate contamination, when bits of a drug’s packaging or components from the manufacturing process worm their way into the product itself, has sparked multiple recalls in recent years, often accompanied by warnings of serious potential complications for those who take the polluted meds.
Last April, Aurobindo’s Eugia unit yanked one lot of injectable methocarbamol after a customer complaint flagged the presence of white particles in a product vial. And, a month before that, Endo’s Par Pharmaceutical recalled one batch of treprostinil injection over fears that silicone particles had made their way into certain vials.
Injecting particulate matter can cause a range of side effects, from the aggravating but ultimately benign—like irritation at the injection site—to the severe, such as stroke or death, Par cautioned in its recall alert.