FDAFDA · Food and drugs·Recall number D-0405-2025
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
Published May 14, 2025 · Recall initiated: April 23, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations and lack of assurance of sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BRS Analytical Services, LLC
- Distributor
- Nationwide in the USA
- Lot
- Lot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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