D-0991-2019 Class III Terminated
FDA drug recall D-0991-2019 was initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on Mar 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 Sep 11, 2019). Affected quantity: 112 folding cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 20, 2019
- Initiation Date
- Mar 7, 2019
- Termination Date
- Sep 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0991-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026