Pramipexole Dihydrochloride Extended Release Tablets recall: Impurity Out of Spec
Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc.…
Why was Pramipexole Dihydrochloride Extended Release Tablets 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s: 27409201, 27409301, 27409401, Exp. 02/2017; 27662101, Exp. 07/2017
- Product
- Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc.…
- Recalling firm
- Par Pharmaceutical
- Quantity
- 12,535 bottles
- Distribution
- Nationwide and Puerto Rico.
- Recall date
- June 22, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)