Data Composite

Recall D-0404-2025

US Class II Ongoing · initiated 2025-04-23

Recalling firm

BRS Analytical Services, LLC, MO

Product

Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.

Reason for recall

cGMP deviations and lack of assurance of sterility.

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