FDA recall D-1449-2014

Shamrock Medical Solutions Group LLC · Class II · drug

Product

Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01

Reason for recall

Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets

Distribution

Product was shipped to the following states: CO, MA, OH, TX & WY.

Key facts

Status: Terminated
Initiation date: 2011-09-27
Report date: 2014-07-30
Termination date: 2014-07-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lewis Center, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1449-2014