Hospira Recalls Sodium Bicarbonate Injection

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Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

Hospira, a Pfizer company, announced on March 18, 2016 that the company is voluntarily recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) because of particulate matter found in a single-dose fliptop vial. The particulate matter was found after a confirmed complaint. Hospira stated in their press release that the company is conducting an investigation to determine the root cause and corrective and preventive actions. As of March 18, the company had not received any reports of adverse events.

The recalled product is packaged 50 mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50mL, single-dose, packaged as 4 boxes of 25 vials per case and was distributed nationwide in the United States to wholesalers and hospitals in December 2015. According to the company, “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.”

Hospira states that if the product containing the particulate matter is administered and the particulate breaks into smaller pieces, it may result in localized inflammation, allergic reaction, granuloma formation, or microembolic effects. The company is recommending that existing inventory should be quarantined immediately.


Source: FDA