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.
Reason for recall: Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Recall initiated: 20150121
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated