Reported Jun 22, 2016 · Terminated
Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par…
Par Pharmaceutical
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Par Pharmaceutical · 6 Ram Ridge Rd · Chestnut Ridge, NY · 10977-6713
Is this the product you have?
- Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles
- Manufactured ByPar Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
- Lot codes and dates
Lot #s: 274092012740930127409401Exp. 02/201727662101Exp. 07/2017
- Amount recalled
- 12,535 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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