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 # AA3280A
    • Exp 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 11, 2019 · Data as of Sep 19, 5:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.