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

Recalled January 17, 2018 · FDA recall D-0201-2018 · KRS Global Biotechnology

Hazard

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. · FDA Class II

Units

297 droptainers

Sold at

Nationwide in the USA, Bermuda, and New Zealand

Description

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.

Product

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.

Manufacturer(s)

KRS Global Biotechnology, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →