Huons recalls Carboxymethylcellulose Sodium 0.5% Lubricant Eye Drops over failed impurity specification
The eye drops failed the impurities and degradation specification, and polyethylene (PE)-related oligomers were detected, and the notice does not say what this could do to a person.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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 Pouch Label: Carboxymethylcellulose Sodium, Lubricant Eye Drops, 0.5 mL, Single-Use, gsms.
- Company
- Huons Co., Ltd.
- Hazard
- Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers
- Units
- 6,633,570 tubes
- Where sold
- Nationwide within U.S.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- October 26, 2026
- Recall started
- October 2, 2026
- FDA enforcement report
- November 4, 2026
- Identifiers
- Codes: 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.
- FDA recall number: D-0080-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 Pouch Label: Carboxymethylcellulose Sodium, Lubricant Eye Drops, 0.5 mL, Single-Use, gsms.
- Reason for recall
- Failed Impurities/Degradation Specification; detection of polyethylene (PE)-related oligomers
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide within U.S.
- Quantity
- 6,633,570 tubes
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