Hospira Sodium Bicarbonate Injection Recall [US]

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US/Silver Spring: FDA Logo BlueHospira recalls one batch/lot of Sodium Bicarbonate Injection, USP due to possible particulate contamination, a serious health hazard. FDA: http://ht.ly/ZM3Cq

Direct link: http://www.fda.gov/Safety/Recalls/ucm491476.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drug is subject to this recall

  • 8.4% Sodium Bicarbonate Injection, USP; NDC: 0409-6625-02, lot 56-148-EV, expiry date: 1AUG2017

The product is packaged 50 mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50mL, Single-dose, packaged four (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.

According to the FDA, Hospira, Inc., a Pfizer company, has recalled one batch/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. 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 received no reports of any adverse events associated with this batch/lot of Sodium Bicarbonate Injection, USP.

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.

If you believe you have purchased or have in your possession any of the recalled Drug, please do not administer it. Instead, kindly return the product to the outlet/distributor where you purchased it for a full refund. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.

If you have any questions about this recall, please contact Stericycle at 1-888-965-6077 between the hours of 8:00 AM to 5:00 PM Eastern Standard Time, Monday through Friday. For clinical inquiries, please contact Hospira using the information provided below.

==> To report Adverse Events or Product Complaints:
Hospira Global Complaint Management at 1-800-441-4100 8:00 AM to 5:00 Central Standard Time Monday through Friday or by e-mail at ProductComplaintsPP@hospira.com.

==> For Medical Inquiries:
Hospira Medical Communications at 1-800-615-0187 or by e-mail at medcom@hospira.com, available 24 hours-a-day, 7 days-a-week.

Want to read more about this recall? Please click on the links above to visit the originating site.

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Additional information about this recall:
Recalls Direct RIN: 6718-2016
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