The company is recalling the drug for the presence of particulate matter
Sun Pharma has decide to recall 5,322 bottles of Ketorolac Tromethamine ophthalmic solution in the US market for failing to meet specifications. The ophthalmic solution falls under non-steroidal anti-inflammatory drug (NSAID) category and is indicated for relief from pain and inflammation in the eyes.
The company is recalling the drug for the presence of particulate matter in the 5,322 batch of bottles.
The drug was manufactured by the company's Halol facility in Gujarat.
It has been classified as a Class-II recall which FDA defined as "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".