Class II
Terminated
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
This recall has been terminated (originally issued October 9, 2019).
- Company
- Krs Global Biotechnology, Inc
- Recall Initiated
- September 12, 2019
- Posted
- October 9, 2019
- Recall Number
- D-0090-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 317 vials
- Firm Location
- Boca Raton, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide
Lot / Code Info
All lots remaining within expiry.
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