FDA-Drug2015-03-04Class II
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.
Sun Pharma Global Fze
Hazard
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Sold states
Nationwide and Puerto Rico
Affected count
5322 bottles
Manufactured in
Office # 43 Block Y Saif Zone, N/A, Sharm, N/A, United Arab Emirates
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0394-2015Don't want to check this manually?
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