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Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boe...

FDA Recall #D-0051-2021 — Class II — October 5, 2020

Recall #D-0051-2021 Date: October 5, 2020 Classification: Class II Status: Terminated

Product Description

Catapres (clonidine hydrochloride, USP) 0.1 mg, tablet, 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877, Made in Germany, NDC, 0597-0006-01

Reason for Recall

An extraneous peak was observed for dissolution 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

13,270 bottles/100 tablets each

Distribution

Distributed Nationwide in the USA and Puerto Rico

Code Information

Lot # 761544, 859015, EXP Jan 2021, 861346, 956626, EXP Jan 2022

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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