FDA Recall Terminated Historical recordClass III
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
- Reason
- Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
- Published
- September 19, 2018
- Distribution
- Nationwide
