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
D-1449-2014
Product summary
- Event
- Event 64611
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99/500 mg tablets
- Official record key
drug-enforcement:D-1449-2014
Official wording
Reason: Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Code information: Use by 12/14/2012, Lot# 002B90, NDC 16714-586-01
Distribution pattern: Product was shipped to the following states: CO, MA, OH, TX & WY.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix up