Sun Pharma Global Fze recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laborator…

Recall date

January 21, 2015

Source

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

Recall number

D-0394-2015

FDA classification

Class II

Brand / firm

Sun Pharma Global Fze

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.

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

What was recalled

Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; NDC 41616-219-90, UPC 3 41616 21990 6.