Huons Carboxymethylcellulose Sodium Eye Drops Recalled for Impurities
Huons Co., Ltd. is recalling Carboxymethylcellulose Sodium lubricant eye drops due to the detection of polyethylene-related oligomers.
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 due to the detection of polyethylene-related oligomers, a hazard that may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Huons Co., Ltd. is recalling Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-Use Containers. The recall is being conducted because of a failure in impurities and degradation specifications, specifically the detection of polyethylene (PE)-related oligomers.
The affected product is marketed by GSMS Incorporated and was distributed nationwide within the U.S. The recall involves 6,633,570 tubes across multiple lots with expiration dates ranging from March 12, 2027, to October 13, 2028.
Consumers should stop using the recalled eye drops and return them to the point of purchase or contact the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops, Sterile, 30 Single-Use Containers, 0.02 FL OZ (0.5 mL) each, Manufactured by: Huons Co., Ltd, Jecheon-si, Chungcheongbuk-do, 27159, South Korea; Marketed by: GSMS Incorporated, Camarillo, CA 93012, USA. NDC 51407-945-30…
- Manufacturer
- Huons Co., Ltd.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 6,633,570
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 (19)
- Lot: 2EQH501
- Exp. 3/12/2027
- 2EQH502
- 2EQH503
- 2EQH504
- 2EQH505
- Exp. 3/16/2027
- 2EQH506
- 2EQH507
- Exp. 5/22/2027
- 2EQH508
- Exp. 5/26/2027
- 2EQH509
- Exp. 5/27/2027
- 2EQH510
- 2EQH511
- 2EQH512
- 2EQH513
- Exp. 10/13/2028.
Distribution
Distributed nationwide across the United States.
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