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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
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