FDA-Drug2018-11-07Class II

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

Boehringer Ingelheim Pharmaceuticals, Inc.
Hazard

Failed Dissolution Specifications: OOS resultsduring routine stability testing

Sold states
Distributed nationwide in the USA and Puerto Rico
Affected count
1,380 100-count bottles
Manufactured in
900 Ridgebury Rd, N/A, Ridgefield, CT, United States
Products
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

Official notice

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

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