Mylan Pharmaceuticals Inc. recalls Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Recalled June 21, 2017 · FDA recall D-0920-2017 · Mylan Pharmaceuticals
Hazard
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities · FDA Class III
Units
11,624 pouches
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Product
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Manufacturer(s)
Mylan Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →