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FDA Issues Class II Recall for Zyflo CR


June 20, 2019

Chiesi USA Inc. is recalling 2118 bottles of Zyflo CR (zileuton) extended-release tablets, 600 mg, because samples failed to meet dissolution specifications, according to the June 19, 2019, US Food and Drug Administration (FDA) Enforcement Report.  

The recall affects 120-count bottles (NDC 10122-902-12) from lot 3171855 (Exp. 12/19). The affected bottles were distributed throughout the United States. 

Chiesi USA voluntarily initiated the recall May 31, 2019. On June 13, 2019, the FDA designated the recall Class II. Under Class II recalls, use of the medication could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm. 

Zyflo CR is a prescription anti-inflammatory medication used to prevent and treat asthma symptoms. 

Jolynn Tumolo

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