Ketorolac Tromethamine Ophthalmic Solution — Class II drug recall D-0394-2015
Terminated recall by Sun Pharma Global Fze, reported 2015-03-04, distributed nationwide. Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in
| Recall number | D-0394-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharma Global Fze, Sharm, N/A, United Arab Emirates |
| Recall initiated | 2015-01-21 |
| Classified | 2015-02-20 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2015-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 5,322 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00341616219906 |
| NDC | 41616-0219-90 |
| Lot numbers | 07/15, JKM5035A |
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.
Reason for recall
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0394-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.