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
Reported: October 9, 2019 Initiated: September 12, 2019 #D-0090-2020
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- KRS Global Biotechnology, Inc
- Units Affected
- 317 vials
- Distribution
- Nationwide
- Location
- Boca Raton, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by KRS Global Biotechnology, Inc. Units affected: 317 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2019. Severity: Moderate. Recall number: D-0090-2020.
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