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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 9P367, Exp 12/12
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-192-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 1, 2010
- FDA report date
- Mar 20, 2013
- Quantity
- 31,704 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- K C Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-192-2013, exactly as published.
Show all FDA fields
- City
- Pomona
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 55714
- Address
- 3201 Producer Way
- Code information
- Lot #: 9P367, Exp 12/12
- Postal code
- 91768-3916
- Report date
- Mar 20, 2013
- Product type
- Drugs
- Recall number
- D-192-2013
- Classification
- Class II
- Recalling firm
- K C Pharmaceuticals Inc
- Product quantity
- 31,704 bottles
- Termination date
- Apr 2, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 1, 2010
- Initial firm notification
- Center classification date
- Mar 8, 2013