FDA recall D-0920-2017

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-05-09

Report date

2017-06-21

Termination date

2018-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0920-2017