FDA Recall Terminated Historical recordClass III
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
- Reason
- Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
- Published
- March 20, 2019
- Distribution
- Nationwide
