KRS Global Biotechnology, Inc recalls Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose D…

Recall date

November 16, 2017

Source

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

Recall number

D-0201-2018

FDA classification

Class II

Brand / firm

KRS Global Biotechnology, Inc

Sold / distributed

Nationwide in the USA, Bermuda, and New Zealand

Why it was recalled

Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

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/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5% Ophthalmic Solution, 3 mL Multi Dose Droptainer, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.