Both recalls are due to confirmed reports of floating and/or embedded particulate in the glass vial. The particulate was identified as stainless steel in the 0.25% Bupivacaine vial, and as iron oxide in the 0.75% Bupivacaine vial.
Bupivacaine HCl is indicated for local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
The affected products are as follows:
- Bupivacaine HCl Injection 0.25% (2.5mg/mL): Lot# 18-136-DK; Exp. 6/1/14
- Bupivacaine HCl Injection 0.75% (7.5mg/mL): Lot# 23-338-DK; Exp. 11/1/14
Both products are packaged 25 units per carton/50 units per case in glass teartop vials.
Administering an injectable with the presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis, which may be fatal. Some signs and symptoms include redness, pain, injection site reaction, fever, shortness of breath, tachycardia, nausea, and vomiting.
For more information call (866) 240-5364 or read the Firm press release.