FDA Recall D-0407-2025

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

Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.

Lot / code: Lot, expiry: Lot 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26; Lot 206, exp 12/02/26; Lot 219, exp 2/24/27; Lot 221, exp 3/02/27; Lot 222, exp 3/05/27.

Quantity: 13,104 cases (24 cartons per case)

Reason for recall

cGMP deviations and lack of assurance of sterility.

Recall record

Recall number: D-0407-2025
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): LUBRICANT EYE DROPS SOLUTION
Generic name(s): POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL
Manufacturer(s): AvPAK
NDC(s): 50268-126
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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