K C Pharmaceuticals Recalls Eye Drops With Incorrect Back Labeling
K C Pharmaceuticals is recalling 31,704 bottles of Eye Drops advanced relief because the back labels fail to list three active ingredients.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
K C Pharmaceuticals Inc is recalling 31,704 bottles of Eye Drops advanced relief ophthalmic solution. The product is distributed by Dolgencorp, LLC and was distributed nationwide. The specific lot number is 9P367 with an expiration date of 12/12.
The recall was initiated due to a labeling error where the back of the immediate container does not list three active ingredients: Dextran 70, PEG 400, and povidone. The unit carton and front label are correct.
Consumers with this product should stop using it and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the product.
The recalled product
- 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.
- Manufacturer
- K C Pharmaceuticals Inc
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 31,704
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 9P367
- Exp 12/12
Distribution
Distributed nationwide across the United States.
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