Sun Pharma is voluntarily recalling 5,322 bottles of Ketorolac Tromethamine ophthalmic solution in the US market for failing to meet specifications.
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.
“Lot is not meeting the specification limit for number of particles present in the solution,” it added.
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 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.
The recall was initiated by the company on January 21 this year.
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”.
When contacted, a Sun Pharma spokesperson declined to comment.
Last month, the drug major had recalled 3,263 bottles of epilepsy drug in US market for failing “dissolution specifications”.
The 750 mg tablets in 60-count bottles, were also manufactured by Sun Pharmaceutical Industries at its Halol manufacturing facility.