Glass Particles Lead to Recall of Sensorcaine-MPF Injection

Fresenius Kabi USA is voluntarily recalling a single lot of bupivacaine HCI (Sensorcaine-MPF) injection due to the presence of glass particulate matter.

Fresenius Kabi USA is voluntarily recalling a single lot of bupivacaine HCI (Sensorcaine-MPF) injection due to the presence of glass particulate matter.

The glass was discovered by the company during an inspection of reserve samples of the product, which is used for local or regional anesthesia or analgesia for surgery, diagnostic and therapeutic procedures, and obstetrical procedures.

The recall for Sensorcaine-MPF affects lot number 6111504, product code 470237. The product is supplied as 0.75% strength in a 30 mL single-dose flint-molded vial and packed in units of 25. The expiration date is September 2019, and it was distributed between March 4, 2016, and March 21, 2016.

While the manufacturer has not heard of any adverse events related to the product, administering an injection containing glass particles could result in inflammation and injury. It may also block administration of the drug, which would cause a delay in therapy.

Fresenius Kabi has notified distributors and customers by letter, and it is arranging for the return of the products. Additionally, distributors are being advised to notify their customers of the recall as soon as possible.

The FDA asks individuals to report any adverse reactions to the MedWatch Adverse Event Reporting program.