CLASS II Drug recall · Reported 20 Mar 2013 · FDA Enforcement Report
Eye Drops advanced relief (Dextran recalled by K C Pharmaceuticals
K C Pharmaceuticals is recalling Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, distributed nationwide in the US. The recall was initiated on 1 Mar 2010 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-192-2013
- FDA event ID
- 55714
- Recalling firm
- K C Pharmaceuticals, Pomona, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2010
- FDA classified
- 8 Mar 2013
- Reported
- 20 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 1 Mar 2010 | Recall initiated by company | |
| 8 Mar 2013 | Classified by FDA | +1103 days |
| 20 Mar 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 9P367, Exp 12/12
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from K C Pharmaceuticals
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|---|---|---|---|---|---|
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