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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072.
Recall Number D-192-2013
Classification Class II
Code Info Lot #: 9P367, Exp 12/12
Product Distributed Qty 31,704 bottles
Reason For Recall Labeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.

Event Detail

Event Id 55714
Product Type Drugs
Status Completed
Recalling Firm K C Pharmaceuticals Inc
City Pomona
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-03-01
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide
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