FDA recall D-192-2013

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.

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2010-03-01

Report date

2013-03-20

Termination date

2013-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pomona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-192-2013