Hospira Recalls Injectable Drug For Diabetes Treatment After Particulates DiscoveredC. Dixon
Hospira has recalled an injectable diabetes drug after particulates were found in them.
The drug 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), and it’s being recalled at the Hospital/Institution level. It’s used to treat metabolic acidosis, which can be caused by severe renal disease, uncontrolled diabetes, dehydration, severe diarrhea, circulatory insufficiency, cardiac arrest, and severe lactic acidosis. It can also be used to treat specific drug intoxications.
This is a voluntary recall of three lots of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL). They were distributed by Pfizer nationwide to wholesalers, distributors, and hospitals in the United States and Puerto Rico in August 2017 and September 2017.
The 50ml of solution is contained in flip-top glass vials in a case pack of 4 x 25. The recalled lot numbers are: 79-238-EV, 79-240-EV, and 80-088-EV with NDC# 0409-6625-02. Expiration dates are July 1, 2019, or August 1, 2019.
Glass particles were found in the drug. Potential health consequences include:
- local irritation or swelling
- blockage and clotting in blood vessels — may be life-threatening if a critical organ is affected.
According to the recall information: “The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.”
As of this writing, Hospira has not received any reports of adverse side effects due to these specific lots.
Hospira has already sent recall letters to its direct customers to facilitate the return of the recalled product. If you have medical questions, contact Pfizer Medical Information at 1-800-438-1985 (option 3) between the hours of 8:00 AM to 7:00 PM ET, Monday through Friday. To report adverse events or product complaints, contact Pfizer Safety at 1-800-438-1985 (option 1) 24 hours a day, 7 days per week.