MedicineWatch US
Class III Recall

Teva Pharmaceuticals USA Inc

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
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Classification
Class III
Status
Terminated
Lot
Lot # 3007556A, Exp 5/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Teva Pharmaceuticals USA Inc — Class III Recall | MedicineWatch US