FDA recall D-0991-2019

Boehringer Ingelheim Pharmaceuticals, Inc. · Class III · drug

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 for recall

Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2019-03-07
Report date: 2019-03-20
Termination date: 2019-09-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ridgefield, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0991-2019