KRS Global Biotechnology, Inc recalls Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fil
Recalled October 9, 2019 · FDA recall D-0109-2020 · KRS Global Biotechnology
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
465 syringes
Sold at
Nationwide
Description
Lack of Assurance of Sterility
Product
Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677124
Manufacturer(s)
KRS Global Biotechnology, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →