Pramipexole dihydrochloride extended release tablets recall: Impurity Out of Spec
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
Why was Pramipexole dihydrochloride extended release tablets recalled?
Failed impurities/degradation specifications: Finished product contain a known product impurity about current 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 #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.
- Product
- Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
- Recalling firm
- Par Pharmaceutical, Inc.
- Quantity
- 16,207 (bottles of 30 tablets)
- Distribution
- United States nationwide
- Recall date
- September 19, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)