Product: Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534
Reason for recall: cGMP deviations
Recall initiated: 20230313
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated