Reported Oct 9, 2019 · Terminated
Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of…
KRS Global Biotechnology, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: KRS Global Biotechnology, Inc · 791 Park of Commerce Blvd Ste 600 · Boca Raton, FL · 33487-3633
Is this the product you have?
- Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632
- Lot codes and dates
- All lots remaining within expiry.
- Amount recalled
- 1980 vials
This recall covers 80 products
The agency filed one notice per product. You are reading one of them; the other 79 are below.
67 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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