Cyclopentolate HCl 1% / Phenylephrine HCl 2 recalled over sterility concerns

Recall date

September 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 Fi…

Recall number

D-0109-2020

FDA classification

Class II

Brand / firm

KRS Global Biotechnology, Inc

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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