FDA recall D-0128-2019

Product

Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01

Reason for recall

Failed Dissolution Specifications: OOS resultsduring routine stability testing

Distribution

Distributed nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-10-22

Report date

2018-11-07

Termination date

2023-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ridgefield, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0128-2019