FDA Drug recall D-0991-2019
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer In…
- FDA Drug
- Class III
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class III recall of Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer In… by Boehringer Ingelheim Pharmaceuticals, citing failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0991-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-07 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Boehringer Ingelheim Pharmaceuticals |
| Distribution | US |
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.
Reason
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Identifiers
| code_info | Lot # AA3280A, Exp SEP 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0991-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.