Product: Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Reason for recall: Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Recall initiated: 20170509
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated