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.
FDA recall notice · announced March 20, 2019 · Boehringer Ingelheim Pharmaceuticals
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The 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.
Reason for recall
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot # AA3280A, Exp SEP 2019
Quantity: 112 folding cartons
Status: Terminated
Products in this recall event:
- 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, (D-0991-2019)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.