FDAFDA · Food and drugs·Recall number D-1038-2016
Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
Published June 22, 2016 · Recall initiated: May 28, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Par Pharmaceutical
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot #s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.