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

Recall Number: D-0510-2023

Firm: Teva Pharmaceuticals USA Inc

Classification: Class III

Status: Terminated

Report Date: 20230412

Initiation Date: 20230327

Termination Date: 20230823

Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.

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