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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Product Detail

Product Description 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,
Recall Number D-050-2013
Classification Class III
Code Info Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
Product Distributed Qty 22 units
Reason For Recall Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."

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.