CLASS II Drug recall · Reported 4 Mar 2015 · FDA Enforcement Report
Ketorolac Tromethamine Ophthalmic Solution recalled
Sun Pharma Global Fze is recalling Ketorolac Tromethamine Ophthalmic Solution, 0.5%, distributed nationwide in the US. The recall was initiated on 21 Jan 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0394-2015
- FDA event ID
- 70382
- Recalling firm
- Sun Pharma Global Fze, Sharm, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2015
- FDA classified
- 20 Feb 2015
- Reported
- 4 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Particulate Matter
- Drug class
- Pain Medication
Timeline
| 21 Jan 2015 | Recall initiated by company | |
| 20 Feb 2015 | Classified by FDA | +30 days |
| 4 Mar 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Which lots are affected?
Lot #: JKM5035A, Exp 07/15
Where was it sold?
Nationwide and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ketorolac Tromethamine recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ketorolac Tromethamine Injection, USP, 60 mg recalled by Aspiro PharmaKetorolac Tromethamine | Aspiro Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |