Sodium Bicarbonate Syringes Recalled for Lack of Sterility Assurance
KRS Global Biotechnology is recalling 540 syringes of Sodium Bicarbonate 8.4% for IV use due to a lack of assurance of sterility.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe. While no injuries are explicitly reported, the lack of sterility assurance in an IV product represents a significant risk of harm, aligning with the Severe classification for high-risk medical products where the defect is structural/process-related.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 540 syringes of Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL (50 mEq / 50 mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use. The product is identified by NDC 3321674199. The recall covers all lots remaining within their expiry dates.
The recall was initiated due to a lack of assurance of sterility. The product was distributed nationwide. The source text does not specify the number of affected units beyond the total quantity of 540 syringes, nor does it report any specific illnesses or injuries associated with the use of the product.
Healthcare providers and facilities that have received this product should stop using it and contact the recalling firm for instructions on return or disposal. Consumers should not use this prescription-only product and should consult their healthcare provider if they have questions regarding its use.
The recalled product
- Product
- Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — IV Solution
- Hazard
- Affected units
- 540
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)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by KRS Global Biotechnology, Inc 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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