FDA recall D-0009-2015

Mylan Pharmaceuticals Inc. · Class II · drug

Product

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.

Reason for recall

Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2014-07-03
Report date
2014-10-15
Termination date
2016-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2015