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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 (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11
Recall Number D-1359-2015
Classification Class II
Code Info Lot #: C704202, Exp 11/2016; Lot #: C706532, Exp 12/2016; Lot #: C713177, Exp 1/2017; Lot #: C716567, Exp 2/2017, Lot #: C720097, C720098, Exp 3/2017
Product Distributed Qty 88,489 tubes
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