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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 Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), 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-1362-2015
Classification Class II
Code Info Lot #: C690076, C693373, Exp 2/2016; Lot #: C701378, C701376, Exp 4/2016; Lot #: C704164, Exp 5/2016; Lot #: C713687, Exp 8/2016; Lot #: C719467,C718203, Exp 9/2016; Lot #: C723641, Exp 10/2016; Lot #: C683884, Exp 12/2016; Lot #: C697653, Exp 3/2016; Lot #: C710477, Exp 7/2016
Product Distributed Qty 166,070 of 15g tube, 112,720 of 30 g tube
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