Drug product
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.
D-0991-2019
Product summary
- Event
- Event 82310
- Status
- Terminated
- Classification
- Class III
- Quantity
- 112 folding cartons
- Official record key
drug-enforcement:D-0991-2019
Official wording
Reason: Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Code information: Lot # AA3280A, Exp SEP 2019
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.