FDA recall D-0491-2017

Mylan Pharmaceuticals Inc. · Class II · drug

Product

glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10

Reason for recall

Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-01-19
Report date
2017-03-08
Termination date
2017-07-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0491-2017