URGENT: Recall Notice

Re: Carboxymethylcellulose Sodium 0.5% (Lubricant Eye Drops 5mg/1mL)

Recall Notice Form

Date: August 25, 2026

Dear Valued Customer,

One of AvKARE’s manufacturers, Sterling, is initiating a Class 2 Recall to the RETAIL LEVEL. Per Sterling’s recall notice, “this recall has been initiated at the request of the U.S. Food and Drug Administration (FDA) following observations identified during a recent FDA inspection related to manufacturing and aseptic processing controls. Sterling Pharmaceutical Services has not identified confirmed sterility failures or evidence of product contamination. This recall is being conducted as a precautionary measure because the observations may affect the assurance of sterility for the affected products.”

This recall is being carried out with the knowledge of the US Food and Drug Administration. Further use of this product should immediately cease. The below marketed product is subject to the recall. This recall is to the Retail Level Only.

NDC# 50268-068-02 Carboxymethylcellulose Sodium 0.5% (Lubricant Eye Drops 5mg/1mL)
Lot Number Expiry Date Quantity to Return
3161 08/26
NDC# 50268-068-15 Carboxymethylcellulose Sodium 0.5% (Lubricant Eye Drops 5mg/1mL)
Lot Number Expiry Date Quantity to Return
3245 03/27
3260 05/27
3298 06/27
3299 06/27
3300 06/27
3301 07/27
3302 07/27
3305 07/27
3306 07/27

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