Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot #: 9P367, Exp 12/12
Why it was recalled
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.
Recalling firm
- Firm
- K C Pharmaceuticals Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 3201 Producer Way, N/A, Pomona, California 91768-3916
Distribution
- Quantity
- 31,704 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2010-03-01
- FDA classified
- 2013-03-08
- Posted by FDA
- 2013-03-20
- Terminated
- 2013-04-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-192-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.