Sun Pharma Global Fze recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical Laboratori
Recalled March 4, 2015 · FDA recall D-0394-2015 · Sun Pharma Global Fze
Hazard
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution. · FDA Class II
Units
5322 bottles
Sold at
Nationwide and Puerto Rico
Description
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Product
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.
Manufacturer(s)
Sun Pharma Global Fze
Made in
United Arab Emirates
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →