FDA-Drug2017-06-21Class III
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Mylan Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Sold states
Nationwide
Affected count
11,624 pouches
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
Montelukast Sodium Oral Granules, 4 mg pouch, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-6040-93
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0920-2017Don't want to check this manually?
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