FDAFDA · Food and drugs·Recall number D-0991-2019
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.
Published March 20, 2019 · Recall initiated: March 7, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot # AA3280A, Exp SEP 2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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