Why it was recalled
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
Product 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
Lot numbers, UPCs & expiration codes
Use by 12/14/2012, Lot# 002B90, NDC 16714-586-01
Where it was sold
Product was shipped to the following states: CO, MA, OH, TX & WY.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1449-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2011
- FDA report date
- Jul 30, 2014
- Quantity
- 99/500 mg tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shamrock Medical Solutions Group LLC
Original FDA data
Every field from FDA enforcement report D-1449-2014, exactly as published.
Show all FDA fields
- City
- Lewis Center
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 64611
- Address
- 741 Radio Dr
- Code information
- Use by 12/14/2012, Lot# 002B90, NDC 16714-586-01
- Postal code
- 43035-7134
- Report date
- Jul 30, 2014
- Product type
- Drugs
- Recall number
- D-1449-2014
- Classification
- Class II
- Recalling firm
- Shamrock Medical Solutions Group LLC
- Product quantity
- 99/500 mg tablets
- Termination date
- Jul 31, 2014
- Reason for recall
- Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Product was shipped to the following states: CO, MA, OH, TX & WY.
- Recall initiation date
- Sep 27, 2011
- Initial firm notification
- Telephone
- Center classification date
- Jul 23, 2014