Hospira issues a nationwide voluntary recall of one lot of Bupivacaine HCl injection due to presence of visible particulates

Hospira has issued a nationwide voluntary recall of one lot of 0.5 % Marcaine (Bupivacaine HCl injection, USP), 30 ml, single dose vial, preservative free with a lot number 33-545-DD. The recall is at user level. Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars.

The recall was initiated due to confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. The company has attributed the embedded particulate to a supplier’s glass defect and is working with its supplier on implementing corrective and preventive actions.

If the solution containing the particulate is administered, depending on the particle size and number, it could block administration of the drug to the patient, causing a delay in therapy. The particulate size identified is too small. Due to this subvisible size of particulates, it can pass through the catheter and may cause local inflammation, mechanical disruption of tissue or immune response to the particulate. Although very rare, particulate exposed to strong magnetic fields, could potentially dislodge and cause tissue damage.

Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The recalled lot of Marcaine was distributed in November 2013 till March 2014 to wholesalers/ distributors, hospitals and clinics nationwide. The recall is conducted with knowledge of US Food and Drug Administration.