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U.S. Department of Health and Human Services

Enforcement Report - Week of September 2, 2015

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Product Detail

Product Description Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.
Recall Number D-1361-2015
Classification Class II
Code Info 15 g: Lot #: C695549, Exp 03/2016; 30 g: Lot #: C707836, Exp 7/2016; C718209, Exp 9/2016.
Product Distributed Qty 28,480 tubes of 15g, 12,234 tubes of 30g
Reason For Recall Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.

Event Detail

Event Id 71920
Product Type Drugs
Status Ongoing
Recalling Firm GlaxoSmithKline, LLC.
City Zebulon
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2015-08-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico