Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL - recalled due to waterborne microbial contamination, USA

United States

Company name: SterRx, LLC
Brand name: SterRx, LLC
Product recalled: Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL
Reason of the recall: Due to waterborne microbial contamination
FDA Recall date: August 10, 2021
Recall details: SterRx, LLC today announced the voluntary nationwide recall of three lots of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL due to waterborne microbial contamination. SterRx, LLC has initiated this voluntary recall of Sodium Bicarbonate injection, to the Hospital Pharmacy level. Intravenous administration of Sodium Bicarbonate in 5% Dextrose Injection 150mEq 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.

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.

The product is supplied in 1000 mL IV bags. The lot numbers being recalled were distributed to hospitals nationwide from May – June 2021.

- Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL (12.6 mg per mL). NDC: 70324-326-01. Lot | Exp. Date | Distribution Dates: BUP | 03/23/22 | 06/01/21-06/02/21. BUI | 03/16/22 | 05/21/21 – 05/25/21. BTW | 03/08/22 | 05/11/21-05/12/21.

Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product.

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sterrx-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-5-dextrose-injection-150meq-1000-ml

Source: FDA