Class II
Terminated
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.
- Company
- Sun Pharma Global Fze
- Recall Initiated
- January 21, 2015
- Posted
- March 4, 2015
- Recall Number
- D-0394-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5322 bottles
- Firm Location
- Sharm, United Arab Emirates
Reason for Recall
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot #: JKM5035A, Exp 07/15
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