CLASS II Drug recall · Reported 30 Jul 2014 · FDA Enforcement Report
Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx recalled
Shamrock Medical Solutions Group is recalling Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain, distributed in Colorado, Massachusetts, Ohio, Texas, Wyoming. The recall was initiated on 27 Sep 2011 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1449-2014
- FDA event ID
- 64611
- Recalling firm
- Shamrock Medical Solutions Group, Lewis Center, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2011
- FDA classified
- 23 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 27 Sep 2011 | Recall initiated by company | |
| 23 Jul 2014 | Classified by FDA | +1030 days |
| 30 Jul 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Product was shipped to the following states: CO, MA, OH, TX & WY.
Questions about this recall
Why was it recalled?
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Which lots are affected?
Use by 12/14/2012, Lot# 002B90, NDC 16714-586-01
Where was it sold?
Product was shipped to the following states: CO, MA, OH, TX & WY.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 64611This product is part of a recall event; the main page for the event is metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS II | Docusate Calcium Softgel Capsules, 240 mg recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS I | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS I | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states | |
| CLASS II | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
More recalls from Shamrock Medical Solutions Group
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg recalledSulfamethoxazole And Trimethoprim | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS I | Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS I | Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS II | Docusate Calcium Softgel Capsules, 240 mg recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
| Drug | CLASS I | metFORMIN ER Tablets, 500 mg, Rx, Packaged recalled | Shamrock Medical Solutions Group | Packaging Defects | 5 states |
Other Pramipexole Dihydrochloride recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pramipexole Dihydrochloride Tablets 0.125 mg recalledPramipexole Dihydrochloride | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.25 mg (10 recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.5 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 1.0 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.125 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |