Recalls / Class III
Class IIID-0991-2019
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.
- Affected lot / code info
- Lot # AA3280A, Exp SEP 2019
Why it was recalled
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Recalling firm
- Firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 900 Ridgebury Rd, N/A, Ridgefield, Connecticut 06877-1058
Distribution
- Quantity
- 112 folding cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-03-07
- FDA classified
- 2019-03-11
- Posted by FDA
- 2019-03-20
- Terminated
- 2019-09-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0991-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.