FDA recall D-0492-2017

Mylan Pharmaceuticals Inc. · Class II · drug

Product

Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV

Reason for recall

Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-01-19
Report date
2017-03-15
Termination date
2017-07-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0492-2017