KRS Global Biotechnology Recalls Polidocanol Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 317 vials of Polidocanol 5% for IV use nationwide 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an IV product.
Plain-English summary
KRS Global Biotechnology, Inc. is recalling 317 vials of Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use. The product is identified by NDC 3321677749 and is distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.
The recall includes all lots remaining within their expiry dates. The product is prescription-only and intended for intravenous use. No specific dates of distribution or additional details regarding the sterility failure are provided in the source text.
Healthcare providers and patients should stop using the recalled product and contact the manufacturer or their supplier for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749
- Manufacturer
- KRS Global Biotechnology, Inc
- Category
- Drug — Injectable
- Affected units
- 317
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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