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Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringe...

FDA Recall #D-0128-2019 — Class II — October 22, 2018

Recall #D-0128-2019 Date: October 22, 2018 Classification: Class II Status: Terminated

Product Description

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

Recalling Firm

Boehringer Ingelheim Pharmaceuticals, Inc. — Ridgefield, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1,380 100-count bottles

Distribution

Distributed nationwide in the USA and Puerto Rico

Code Information

Lot: 757739, EXP 9/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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