India's Sun Pharma hit by a new recall of ketorolac tromethamine solution eye drug

Sun Pharmaceuticals issued a recall of 5,322 bottles of one of its eye drugs after particulate matter was found in a test batch. The ketorolac tromethamine solution, a generic, was made in India and distributed in the United States and Puerto Rico by Sun's U.S. unit, Caraco, which has since been shut down.

Sun initiated the class II recall Jan. 21, but the U.S. FDA just recently posted it among its enforcement reports. The ophthalmic drug was produced at Sun's plant in Gujarat, India.

The specific drug involved was the prescription-only 0.5% solution in 3-ml bottles. The particles found in the test batch were not identified and Sun declined to comment.

The new recall came two weeks after Sun had issued another recall for an epilepsy drug.

- here's the FDA enforcement report
- and a story from The Hindu Business Line