Lot 33-545-DD of 0.5% Marcaine (Bupivacaine HCI injection) 30ml vials was voluntarily recalled throughout the US after a customer reported “particulate embedded in the glass vial as well as visible particulate in the solution.”
Hospira spokesman Daniel Rosenberg told in-Pharmatechnologist.com the company has traced the fault to a supplier’s glass defect and it was working with the supplier “on implementing corrective and preventive actions.”
To date, the drugmaker had not received reports of any adverse events associated with these impurities, it told us. The company did not answer how the contaminated batch came to pass Hospira’s own safety checks, or what the particulates consisted of.
Adverse risks
Hospira added that if the faulty solution is given to patients, “depending on the particle size and number – it could block administration of the drug to the patient, causing a delay in therapy. However, this is an unlikely outcome due to the size of the subvisible particulates identified. It is more likely that particulates are able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate.
“While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage. However, the particulate size identified is considered too small. Therefore, an adverse outcome is extremely unlikely.”
Hospira advised anyone with inventory from the affected batch to “immediately stop use and quarantine” the product.
The impacted lot of Marcaine was distributed from November 2013 to March 2014 to US wholesalers and hospitals. It is in glass flip-top vials of 100 per case, and 10 units per carton.