D-0991-2019 Class III Terminated
FDA drug recall D-0991-2019 was initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on March 7, 2019 and is designated Class III. Reason for recall: Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing. The recall status is terminated (terminated September 11, 2019). Affected quantity: 112 folding cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 20, 2019
- Initiation Date
- March 7, 2019
- Termination Date
- September 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 112 folding cartons
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # AA3280A, Exp SEP 2019