# FDA recall D-0394-2015

> **Sun Pharma Global Fze** · Class II · drug recall initiated 2015-01-21.

## 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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0394-2015
- **Recalling firm:** Sun Pharma Global Fze
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-01-21
- **Report date:** 2015-03-04
- **Termination date:** 2015-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sharm, N/A, United Arab Emirates

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0394-2015

## Citation

> AI Analytics. FDA recall D-0394-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0394-2015. Source: US FDA. Licensed CC0.

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