drugs Class II Updated 2015-03-04

Sun Pharma Global Fze recalls Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottl

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: JKM5035A, Exp 07/15
View official government recall

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