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 | |
| Distribution Pattern | Nationwide |
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