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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 62940
Product Type Drugs
Status Completed
Recalling Firm Stat Rx USA
City Gainesville
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-18
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern FL, PA, and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05, Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14 Class III Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution." 22 units D-050-2013
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