Key Takeaway

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 1 by Shamrock Medical Solutions Group LLC was recalled on September 27, 2011. The hazard: Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets

FDA Drug 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 1

Recalled: September 27, 2011 ~99/500 mg tablets units affected D-1449-2014

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

Hazard / Reason

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

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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 1

Drugs

Company Information

Shamrock Medical Solutions Group LLC

Lewis Center, OH, United States

View all 6 recalls by Shamrock Medical Solutions Group LLC →

Distribution

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

Related Recalls

Frequently Asked Questions

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

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Where can I find the original recall notice?

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