SterRx Sodium Bicarbonate Injection Recalled for Non-Sterility
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.
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 I recall of a sterile injectable drug with confirmed microbial contamination. Non-sterile intravenous products pose direct risk of serious infection, sepsis, or other life-threatening complications in patients, even without reported illnesses stated in the source text.
Plain-English summary
SterRx, LLC is recalling Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), in 1,000 mL bags (NDC 70324-326-01). The recall was initiated because a third-party laboratory confirmed microbial contamination in the product, meaning the solution is not sterile as required for intravenous injection.
Lot Number BUP with expiration date 03/23/22 is affected. Approximately 1,098 bags were distributed nationwide in the United States as a prescription-only medication.
Patients and healthcare providers who have received or are using this product should stop use immediately and consult with a healthcare professional about potential exposure. Healthcare facilities should quarantine and return remaining inventory of the affected lot to the manufacturer.
The recalled product
- Product
- Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01
- Manufacturer
- SterRx, LLC
- Category
- Drug — Intravenous Injection
- Hazard
- non-sterility
- microbial-contamination
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 (2)
- Lot Number: BUP
- exp. date 03/23/22
Distribution
Distributed nationwide across the United States.
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