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ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by ...

FDA Recall #D-1341-2019 — Class II — May 31, 2019

Recall #D-1341-2019 Date: May 31, 2019 Classification: Class II Status: Terminated

Product Description

ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.

Reason for Recall

Failed Dissolution Specifications: Out of specification result for dissolution.

Recalling Firm

Chiesi USA, Inc. — Cary, NC

Classification

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

Product Type

Drugs

Product Quantity

2118 bottles

Distribution

Nationwide in the USA.

Code Information

Lots: 3171855, Exp. 12/19

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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