Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10

Recall Number: D-0823-2020

Firm: Macleods Pharma Usa Inc

Classification: Class III

Status: Terminated

Report Date: 20200205

Initiation Date: 20200120

Termination Date: 20210426

Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product

Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10