Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablet...
FDA Recall #D-1449-2014 — Class II — September 27, 2011
Product Description
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
Recalling Firm
Shamrock Medical Solutions Group LLC — Lewis Center, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
99/500 mg tablets
Distribution
Product was shipped to the following states: CO, MA, OH, TX & WY.
Code Information
Use by 12/14/2012, Lot# 002B90, NDC 16714-586-01
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated