Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial, according to an FDA press release. The issue was identified through a confirmed complaint.
If the particulate is not observed prior to IV administration and breaks off into smaller particulates, passing through the catheter, it may result in localized inflammation, allergic reaction, including anaphylaxis, granuloma formation or microembolic effects (IV only). Larger particulates may block the infusion of solution, potentially resulting in a delay in therapy.
To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
The product is packaged 50 mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50mL, Single-dose, packaged 4 boxes of 25 vials per case. The lot was distributed nationwide in the U.S. to wholesalers and hospitals in December 2015. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.
Read the full release