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U.S. Department of Health and Human Services

Enforcement Report - Week of March 26, 2014

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Product Detail

Product Description Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Recall Number D-1169-2014
Classification Class I
Code Info All lots
Product Distributed Qty
Reason For Recall Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.

Event Detail

Event Id 65892
Product Type Drugs
Status Ongoing
Recalling Firm Fabscout Entertainment, Inc
City Ft Lauderdale
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-27
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide and France
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