Reported Mar 20, 2019 · Terminated
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only,…
Boehringer Ingelheim Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boehringer Ingelheim Pharmaceuticals, Inc. · 900 Ridgebury Rd · Ridgefield, CT · 06877-1058
Is this the product you have?
- Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only
- Distributed byBoehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61
- Lot codes and dates
Lot # AA3280AExp SEP 2019
- Amount recalled
- 112 folding cartons
Where it was sold
- Nationwide
Why it was recalled
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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