Drug recall: Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: Caraco Pharmaceutical…
Class II FDA enforcement event 70382. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Sun Pharma Global Fze started this drug recall on 21 Jan 2015. The firm address in the FDA record is in Sharm. FDA put the recall in Class II. FDA event 70382 has 1 product record. The first FDA enforcement report date is 4 Mar 2015. The record gives the status Terminated, with the termination date 23 Oct 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide and Puerto Rico
Recalling firm
Sun Pharma Global Fze, Sharm, N/A, United Arab Emirates.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0394-2015 | 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. | 5322 bottles | Class II | Terminated | 4 Mar 2015 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2015
- 292
- Share of these events in Class II
- 52%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 11 Feb 2016 | Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. | Drug | Class II | 1 |
| 17 Jul 2015 | buPROPion Hydrochloride Extended-release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by | Drug | Class III | 1 |
| 21 Jan 2015 | Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd H | Drug | Class II | 1 |
Official channels
- FDA enforcement report D-0394-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 70382. https://recallregister.com/fda/ii/70382/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide and Puerto Rico
- What quantity of product is in FDA event 70382?
- The FDA record gives this quantity:
5322 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2015 have the same class?
- 52% of the 292 drug events that started in 2015 are in Class II.