MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: Sodium Bicarbonate in 5% Dextrose Injection 150 mEq per 1,000 mL by SterRx: Recall - Due to Microbial Contamination
AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy
ISSUE: SterRx is recalling three lots of sodium bicarbonate in 5% dextrose injection 150 mEq per 1,000 mL due to waterborne microbial contamination.
Intravenous administration of sodium bicarbonate in 5% dextrose injection 150 mEq per 1,000 mL, intended to be sterile that is not sterile, could result in site specific infections as well as serious systemic infections which may be life-threatening.
To date, SterRx has not received reports of any adverse events associated with this issue.
For the lot numbers and more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Sodium bicarbonate injection is indicated for the following conditions:
High Potassium (Hyperkalemia)
Irregular heartbeat (QRS prolongation ex. tricyclic antidepressant poisoning)
Metabolic acidosis related to severe renal disease, uncontrolled diabetes, severe primary lactic acidosis, circulatory insufficiency due to shock, severe dehydration, extracorporeal circulation of blood, cardiac arrest, drug toxicities, barbiturates, salicylate, toxic alcohols, urine alkalization, severe diarrhea with HCO3 loss.
RECOMMENDATIONS:
Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product.
Healthcare workers who have medical questions about Sodium Bicarbonate in 5% Dextrose injection may contact SterRx.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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