Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Recall Number: D-0920-2017
Firm: Mylan Pharmaceuticals Inc.
Classification: Class III
Status: Terminated
Report Date: 20170621
Initiation Date: 20170509
Termination Date: 20180214
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Product Description
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93