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FDA (Drug enforcement)Recalled 2025-04-23class ii

BRS Analytical Services, LLC: 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,

Hazard

cGMP deviations and lack of assurance of sterility.

Details from the source

Reason for recall: cGMP deviations and lack of assurance of sterility. Distribution: Nationwide in the USA Quantity: 13,872 cases (24 cartons per case) Lot/code info: Lot, expiry: Lot 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26; Lot 195, exp 10/14/26; Lot 196, exp 10/17/26; Lot 197, exp 10/21/26; Lot 198, exp 10/24/26; Lot 199, exp 10/30/26.

Source

Official record: FDA (Drug enforcement)

Republished from the official source above; details can change — the source record controls.

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