FDA reported on Sept. 13, 2013 that Hospira had initiated on July 12, 2013 a voluntary nationwide recall to the user level for one lot of 0.25% bupivacaine HCl injection, USP (2.5 mg/mL), 30-mL single-dose vial (NDC 0409-1159-02). An expanded recall was issued on Aug. 29, 2013 for one lot of 0.75% bupivacaine HCl injection, USP (7.5 mg/mL), 30-mL single-dose vial (NDC 0409-1165-02). Bupivacaine is indicated for the production of local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures.
Both recalls are due to confirmed customer reports of particulate floating and/or embedded in the glass vial, according to FDA. The particulate was identified as stainless steel ranging in size from 542 microns to 1700 microns in Lot 18–136-DK (0.25% bupivacaine) and as iron oxide with an average size of 2000 microns in Lot 23-338-DK (0.75% bupivacaine). To date, Hospira has not received reports of any adverse events associated with this issue.
Both products are packaged 25 units per carton/50 units per case in glass teartop vials. Lot 18-136-DK was distributed August 2012 through September 2012. Lot 23-338-DK was distributed January 2013 through May 2013. Both lots were distributed nationwide to wholesalers/distributors, hospitals and pharmacies.