SterRx, LLC is voluntarily recalling 3 lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1000mL to the hospital pharmacy level due to waterborne microbial contamination.
The 3 recalled lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1000mL; NDC# 70324-326-01, were distributed to hospitals nationwide between May and June 2021 and include the following:
- Lot Number BUP; Exp Date 3/23/22; Distribution Dates 6/1/21-6/2/21;
- Lot Number BUI; Exp Date 3/16/22; Distribution Dates 5/21/21-5/25/21;
- Lot Number BTW; Exp Date 3/8/22; Distribution Date 5/11/21-5/12/21.
Sodium Bicarbonate Injection is indicated in the treatment of metabolic acidosis related to severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis.
The product is also approved for use in the treatment of certain drug intoxications, including barbiturates, in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments.
Sodium bicarbonate also is indicated in severe diarrhea with significant loss of bicarbonate.
According to the Company, intravenous administration of the affected product could lead to “site specific infections as well as serious systemic infections which may be life-threatening.” To date, the Company has not received any reports of adverse events related to this recall.
Adverse events associated with the recall should be reported to the FDA’s MedWatch program.
For more information regarding this recall contact SterRx by calling (518) 324-7879, Extension 216.
SterRx, LLC issues voluntary nationwide recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to microbial contamination. News release. SterRx, LLC. Accessed August 11, 2021. https://www.prnewswire.com/news-releases/sterrx-llc-issues-voluntary-nationwide-recall-of-sodium-bicarbonate-in-5-dextrose-injection-150meq-per-1-000-ml-due-to-microbial-contamination-301352539.html.