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) / Ketorolac
Recalled October 9, 2019 · FDA recall D-0106-2020 · KRS Global Biotechnology
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
1815 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) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510
Manufacturer(s)
KRS Global Biotechnology, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →