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
Product summary
- 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
Labeling: Label Mix-Up: Incorrect