PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: July 30, 2014 Initiated: September 27, 2011 #D-1449-2014

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

Details

Units Affected
99/500 mg tablets
Distribution
Product was shipped to the following states: CO, MA, OH, TX & WY.
Location
Lewis Center, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by Shamrock Medical Solutions Group LLC. Units affected: 99/500 mg tablets.
Why was this product recalled?
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Which agency issued this recall?
This recall was issued by the FDA Drug on July 30, 2014. Severity: Moderate. Recall number: D-1449-2014.