Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Glenmark Pharmaceuticals Inc., USA is recalling one lot of Esomeprazole Magnesium Delayed-Release Capsules. The recall is due to Out of Specification (OOS) result reported for the test of organic impurities for the drug product at the 18 month time point in long term stability study (250C/60% RH). The recalled lot has an expiry date of November 2023.
Leave a Comment
You must be logged in to post a comment.