Status
Terminated
Drug Enforcement D-192-2013
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.
Classification
Class II
Report Date
March 20, 2013
Termination Date
April 2, 2013
Product Information
- 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.
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- K C Pharmaceuticals Inc
- Address
-
3201 Producer Way, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-192-2013
- Event ID
- 55714
- Recall initiation date
- March 1, 2010
- Center classification date
- March 8, 2013
- Code info
- Lot #: 9P367, Exp 12/12
- More code info
- —