Hospira announced a voluntary recall of one lot of Sodium Bicarbonate Injection 8.4%, USP, due to particulate presence within a single-dose glass fliptop vial from a confirmed complaint.
If the presence of particulate is not detected prior to intravenous (IV) administration and breaks up into smaller particulate, it may lead to localized inflammation, allergic reaction (anaphylaxis), granuloma formation, or microembolic effects. Larger particulates may block the solution infusion that may result in a delay in therapy.
The affected product was packaged in 50mEq (1mEq/mL), 4.2g (84mg/mL), 50mL, single-dose vials in 4 boxes of 25-count cases. The recalled lot # 56-148-EV with an expiration date of 8/1/2017 was distributed to wholesalers and hospitals in December 2015.
Sodium Bicarbonate Injection is indicated for the treatment of metabolic acidosis, in certain drug intoxications, in poisoning by salicylates or methyl alcohol, and in some hemolytic reactions. It is also indicated for severe diarrhea where there is usually a significant loss of bicarbonate.
Hospira will be notifying its direct customers via letter and is arranging for recalled products to be returned.
For more information call (888) 965-6077 or visit FDA.gov.