Sodium Bicarbonate in 5% Dextrose Injection Lacks Sterility Assurance
SterRx is recalling 2,886 bags of Sodium Bicarbonate in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product may pose a risk to patients who receive this intravenous medication.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 an injectable pharmaceutical product with a sterility defect. Lack of sterility assurance in intravenous medications poses a direct risk of serious infection and adverse health consequences, meeting the criteria for Severe classification.
Plain-English summary
SterRx, LLC is recalling Sodium Bicarbonate in 5% Dextrose Injection (NDC 70324-326-03) distributed nationwide. The recall affects 2,886 bags manufactured by SterRx and distributed across the United States.
The reason for the recall is lack of assurance of sterility. This injectable drug product is required to meet strict sterility standards to ensure patient safety when administered intravenously.
Patients who have received this product should contact their healthcare provider. Healthcare providers should not distribute remaining units and should quarantine and return affected stock. The recalled product was distributed to healthcare facilities nationwide.
The recalled product
- Product
- Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
- Manufacturer
- SterRx, LLC
- Affected units
- 2,886
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- S20459/BMP 17-Nov-21 S20472/BMZ 18-Nov-21 S20473/BNA 18-Nov-21
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by SterRx, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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