FDAClass IIJuly 30, 2014

Pramipexole Dihydrochloride Tablets recall: Labeling Error

Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis…

Why was Pramipexole Dihydrochloride Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Use by 12/14/2012, Lot# 002B90, NDC 16714-586-01

Product
Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis…
Recalling firm
Shamrock Medical Solutions Group LLC
Quantity
99/500 mg tablets
Distribution
Product was shipped to the following states: CO, MA, OH, TX & WY.
Recall date
July 30, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls