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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017
Where it was sold
Nationwide and Puerto Rico.
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-1038-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 28, 2016
- FDA report date
- Jun 22, 2016
- Quantity
- 12,535 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Par Pharmaceutical
Original FDA data
Every field from FDA enforcement report D-1038-2016, exactly as published.
Show all FDA fields
- City
- Chestnut Ridge
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 74270
- Address
- 6 Ram Ridge Rd
- Code information
- Lot #s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017
- Postal code
- 10977-6713
- Report date
- Jun 22, 2016
- Product type
- Drugs
- Recall number
- D-1038-2016
- Classification
- Class III
- Recalling firm
- Par Pharmaceutical
- Product quantity
- 12,535 bottles
- Termination date
- Mar 3, 2017
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- May 28, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 16, 2016