Sun Pharma voluntarily recalls Ketoroloc Tromethamine eye drop in US for failing to meet specifications

Sun Pharma is voluntarily recalling over 5000 bottles of Ketorolac Tromethamine ophthalmic solution in the US market for failing to meet specifications. Last month, Sun Pharma had recalled 3,263 bottles of epilepsy drug in US market for failing “dissolution specifications”. The recall of Ketorolac has been defined as a class 2 recall. A class 2 recalls is defined by USFDA 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. The drug was manufactured by Mumbai-based Sun Pharmaceutical Industries at its Halol facility in Gujarat and distributed by Caraco Pharmaceutical Laboratories in the US market. As per the information available on the USFDA website, Sun Pharma Global Fze, a US—based unit of the company, is recalling the eye drops for “presence of particulate matter” in the 5,322 batch of bottles. Ketorolac Tromethamine ophthalmic solution falls under non-steroidal anti-inflammatory drug (NSAID) category and is indicated for relief from pain and inflammation in the eyes.