Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:

Recall Reason Description

Due to waterborne microbial contamination

Company Name:
SterRx, LLC
Brand Name:

Brand Name(s)

Product Description:

Product Description

Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL

Company Announcement

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.

Product

NDC Number

Lot Number

Exp. Date

Distribution Dates
  Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL (12.6 mg per mL) 70324-326-01 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.  The necessary form by which to document this information, as well as other information regarding this recall, is available at www.sterrx.com.

Customers with any questions about returning unused product should be directed to the customer call center at (518) 324-7879, Extension 207 M-F 8:00am to 5:00pm EST. Healthcare workers who have medical questions about Sodium Bicarbonate in 5% Dextrose injection may contact SterRx at (518) 324-7879, Extension 216 M-F 8:00am to 5:00pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Consumers:
Customer Call Center, Medical Affairs
(518) 324-7879, Extension 207, (518) 324-7879, Extension 216