Product: Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Reason for recall: Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Recall initiated: 20230327
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated