FDA Recall D-0404-2025

BRS Analytical Services, LLC · Saint Louis, MO

Class II Ongoing 386 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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.

Lot / code: 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.

Quantity: 13,872 cases (24 cartons per case)

Reason for recall

cGMP deviations and lack of assurance of sterility.

Recall record

Recall number: D-0404-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-04-23
Classified by FDA Center: 2025-05-06
FDA published: 2025-05-14
Recalling firm: BRS Analytical Services, LLC
Firm location: Saint Louis, MO

Drug identification

Brand name(s): ARTIFICIAL TEARS
Generic name(s): ARTIFICIAL TEARS
Manufacturer(s): AvPAK
NDC(s): 50268-043
Route(s): OPHTHALMIC

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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