Ketorolac Tromethamine Ophthalmic Solution recall: Particulate Matter
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.
Why was Ketorolac Tromethamine Ophthalmic Solution recalled?
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: JKM5035A, Exp 07/15
- 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.
- Recalling firm
- Sun Pharma Global Fze
- Quantity
- 5322 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- March 4, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)