KRS Global Biotechnology Recalls Sodium Citrate and Gentamicin Vials
KRS Global Biotechnology is recalling 150 vials of Sodium Citrate and Gentamicin solution 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a product intended for intra-catheter use, which presents a significant risk of infection or serious injury.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 150 vials of Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL, 30 mL vials for Intra-Catheter Use Only. The product is identified by NDC 3321676603. The recall was initiated because of a lack of assurance of sterility.
The affected product was distributed nationwide. The recall includes all lots remaining within their expiry dates. The product is a prescription-only medication intended specifically for intra-catheter use.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603
- Manufacturer
- KRS Global Biotechnology, Inc
- Affected units
- 150
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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