Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported March 4, 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.
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Sun Pharma Global Fze recalled Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: C… - a moderate-severity action.
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 3 mL bottle, Rx only, Distributed by: C… was recalled by Sun Pharma Global Fze in March 4, 2015. Reason: Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in…. Check the official notice for the remedy. Verify recall #D-0394-2015 with the FDA Drug before acting.
The recall
Sun Pharma Global Fze issued this moderate-severity FDA Drug recall-Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in….
- Moderate
- severity level
- Class II
- classification
- March 4, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0394-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0394-2015) was formally reported on March 4, 2015, with the manufacturer initiating the action on January 21, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Sun Pharma Global Fze is listed as the recalling firm, operating out of Sharm, N/A. Federal records list the affected scope as 5322 bottles.
The documented reason for this recall is: Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution. Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5322 bottles
Related Recalls
6
5 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0394-2015 |
| Date reported | March 4, 2015 |
| Date initiated | January 21, 2015 |
| Recalling firm | Sun Pharma Global Fze |
| Firm location | Sharm, N/A |
| Affected scope | 5322 bottles |
| Distribution | Nationwide and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0394-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sun Pharma Global Fze. Units affected: 5322 bottles.
Why was this product recalled? ▼
Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 4, 2015. Severity: Moderate. Recall number: D-0394-2015.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0394-2015) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 4, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.