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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64325
Product Type Drugs
Status Ongoing
Recalling Firm Lupin Pharmaceuticals Inc.
City Baltimore
State MD
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-31
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03. Lot #s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014 Class III Discoloration; Product may not meet specifications for color description once reconstituted. 64,368 bottles D-264-2013