KRS Global Biotechnology, Inc recalls Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamin
Recalled October 9, 2019 · FDA recall D-0108-2020 · KRS Global Biotechnology
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
649 droptainers
Sold at
Nationwide
Description
Lack of Assurance of Sterility
Product
Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676225
Manufacturer(s)
KRS Global Biotechnology, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →