Presence of Glass Particles Prompts IV Recall from Fresenius Kabi
The recall applies to a single lot of the injection, used to produce local or regional anesthesia
Fresenius Kabi has announced a recall for an intravenous injection due to the presence of a foreign substance.
The drug manufacturer is recalling a single lot of Sensorcaine-MPF Injection. The recall is being performed to the user level due to visible glass particles, observed by the company during inspection of reserve samples.
Sensorcaine-MPF is used for local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures.
Administration of an injection with glass particles may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves. To date, Fresenius Kabi has not received any reports of adverse events.
The product, supplied as 0.75 percent strength in a 30 mL single dose flint molded vial, was packaged in units of 25. Product code 470237, lot number 6111504, and National Drug Code 63323-472-37 are visible on the label.
Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of all recalled product. If health care facilities have the affected lot, they should immediately discontinue distributing, dispensing, or using the lot and return all units.
Consumers with questions about this recall can contact Fresenius Kabi by phone at (800) 551-7176 or by email at productcomplaint.USA@fresenius-kabi.com.