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Recall Observatory FDA recall evidence

Drug product

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.

D-192-2013

March 01, 2010

Class II

Product summary

Firm
K C Pharmaceuticals Inc
Event
Event 55714
Status
Terminated
Classification
Class II
Quantity
31,704 bottles
Official record key
drug-enforcement:D-192-2013

Official wording

Reason: 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.

Code information: Lot #: 9P367, Exp 12/12

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up: Incorrect