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U.S. Department of Health and Human Services

Enforcement Report - Week of April 9, 2014

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Product Detail

Product Description Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.
Recall Number D-1186-2014
Classification Class III
Code Info Lot #s: F300737 Exp. February 2015, F300743 Exp. February 2015
Product Distributed Qty 4,038 bottles
Reason For Recall Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.

Event Detail

Event Id 67462
Product Type Drugs
Status Ongoing
Recalling Firm Lupin Pharmaceuticals Inc.
City Baltimore
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-27
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide