Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall – Presence of Particulate Matter
ISSUE: Fresenius Kabi USA announced today it is voluntarily recalling a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine®-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall is being performed to the user level due to visible particulate matter characterized as glass observed by the company during inspection of reserve samples. Administration of a solution containing glass particulate matter by the epidural or retrobulbar (behind the eyeball) route may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves. If the particulate goes undetected and solution is administered – depending on the particle size and number – it could block administration of the drug to the patient, causing a delay in therapy. If the particulates are able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. To date, Fresenius Kabi has not received any reports of adverse events related to this recall.
BACKGROUND: Sensorcaine®-MPF (bupivacaine HCl) Injection is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures and for obstetrical procedures. The recalled product is labeled with Product Code 470237 and Lot Number 6111504 and is supplied as 0.75% strength in a 30 mL single dose flint molded vial and packaged in units of 25. The product was shipped in the United States to wholesaler and distributor outlets between March 4, 2016 and March 21, 2016 and has an expiration date of September 2019. The NDC number for this product is 63323-472-37.
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