Reported Mar 4, 2015 · Terminated
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by
Sun Pharma Global Fze
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sun Pharma Global Fze · Office # 43 Block Y Saif Zone · Sharm, N/A · N/A
Is this the product you have?
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Caraco Pharmaceutical Laboratories Ltd., 1150 Elijah Mccoy Drive, Detroit, MI 48202 |
| 2 | Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India |
| 3 | NDC 41616-219-90, UPC 3 41616 21990 6. |
- Lot codes and dates
Lot #: JKM5035AExp 07/15
- Amount recalled
- 5322 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
This product could cause temporary or reversible health problems — stop using it.
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