Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Assurance
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The recall affects 127,260 bags distributed across the U.S.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug product with a lack of sterility assurance. Contaminated injectable products pose a direct risk of serious harm through infection and systemic complications, meeting the Severe criteria for injectable pharmaceutical products with sterility defects.
Plain-English summary
SterRx, LLC is recalling Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), NDC 70324-326-01, due to lack of assurance of sterility. Approximately 127,260 bags have been distributed nationwide.
The affected product was manufactured between November 23, 2021 and July 21, 2022, with multiple lot codes spanning this period. Specific lot codes and dates are identified in the recall notice.
Sodium Bicarbonate in 5% Dextrose Injection is a prescription medication administered intravenously. A lack of sterility assurance means the product may not be guaranteed to be free from microorganisms, which could pose a risk to patients who receive the injection.
Patients and healthcare providers who have this product should contact SterRx, LLC at 141 Idaho Ave., Plattsburgh, NY 12903 for guidance on the recalled medication.
The recalled product
- Product
- Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
- Manufacturer
- SterRx, LLC
- Hazard
- lack-of-sterility
- microbial-contamination
- injectable-safety
Distribution
Distributed nationwide across the United States.
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