FDA recall D-0053-2021

Product

Catapres (clonidine hydrochloride, USP) 0.3 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0011-01

Reason for recall

An extraneous peak was observed for dissolution testing.

Distribution

Distributed Nationwide in the USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-10-05

Report date

2020-11-04

Termination date

2021-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ridgefield, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0053-2021