Hospira Voluntarily Recalls One Lot of Bupivacaine
Hospira, Inc. is issuing a voluntary recall of one lot of preservative-free bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as iron oxide. This recall is being carried out to the user level (both human and veterinary).
The lot was distributed from July 2014 to September 2014. Hospira has not received reports of any adverse events associated with this issue for this lot to date. Hospira is currently working with our glass supplier and has initiated an investigation to determine the root cause and corrective and preventive actions.
Source: Hospira and FDA