SterRx Sodium Bicarbonate in 5% Dextrose Injection Recalled for Sterility Concerns
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.
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: The FDA has classified this as a Class II recall. Lack of sterility assurance in an intravenous injection product presents a significant risk of serious adverse health consequences, meeting the criterion for Severe severity under the rubric.
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, distributed nationwide in the United States. The recall was initiated because the firm cannot assure the sterility of the affected product.
The recalled lots are: Lot BTW (expiration date 03/08/22) and Lot BUI (expiration date 03/16/22). A total of 3,378 bags are affected by this recall.
Sodium Bicarbonate in 5% Dextrose Injection is an intravenous medication used for medical purposes. Lack of sterility assurance poses a potential risk to patients who receive the product. Healthcare providers and patients who have this product should stop using it and contact their healthcare provider for guidance.
Patients or healthcare providers with questions about this recall should contact SterRx, LLC or the FDA.
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
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable Solution
- Hazard
- lack-of-sterility
- contamination-risk
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 (3)
- Lot Numbers: BTW
- exp. date 03/08/22 BUI
- exp. date 03/16/22
Distribution
Distributed nationwide across the United States.
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