Hospira Voluntarily Recalls One Lot of Sodium Bicarbonate Injection

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 8.4% sodium bicarbonate injection, USP at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial. The issue was identified through a confirmed complaint. The recall notice was issued March 18, 2016. 

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), 50-mL, single-dose, packaged 4 boxes of 25 vials per case. The lot was distributed nationwide in the US to wholesalers and hospitals in December 2015. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

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. The likelihood of risk to the patient is low due to the high detectability of the particulate prior to or at the point of care. Although serious in nature, the probability of harm in this case is low due to the high detectability of the non-conformance, according to information from Hospira.

Sodium bicarbonate injection, USP is indicated in the treatment of metabolic acidosis; in the treatment of certain drug intoxications, in poisoning by salicylates or methyl alcohol and in certain hemolytic reactions. Sodium bicarbonate also is indicated in severe diarrhea, which is often accompanied by significant loss of bicarbonate.

Source: Hospira and US Food and Drug Administration

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