RecallRadar

FDA Drug recall D-1449-2014

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

On 2014-07-30 the FDA classified a Class II recall of Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutio… by Shamrock Medical Solutions Group, citing labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1449-2014
ClassificationClass II
Statusterminated
Initiated2011-09-27
Published2014-07-30
Last updated2026-09-13 11:51 UTC
CompanyShamrock Medical Solutions Group
DistributionCO, MA, OH, TX, WY

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1449-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.