KRS Global Biotechnology, Inc recalls PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL
Recalled October 9, 2019 · FDA recall D-0085-2020 · KRS Global Biotechnology
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
3150 vials
Sold at
Nationwide
Description
Lack of Assurance of Sterility
Product
PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170
Manufacturer(s)
KRS Global Biotechnology, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →