Recall D-0408-2025

US Class II Ongoing · initiated 2025-04-23

Recalling firm

BRS Analytical Services, LLC, MO

Product

Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.

Reason for recall

cGMP deviations and lack of assurance of sterility.

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