| Reason for the Action |
The manufacturer has advised a recall of a specific batch due to low assay results identified in stability data. The results observed were 93.7% compared to the registered 95%. Although subsequent testing showed the batch was within specification, the manufacturer has decided to recall the batch out of an 'abundance of caution' due to noticing a trend with two other batches.
After analyzing data and evaluating medical assessments, it is determined that there is a minor difference in observation between two values. However, all medical, toxicological, and benefit/risk values remain the same, resulting in no change in the overall benefit/risk balance of montelukast chewable tablets. |