FDA Recall D-0408-2025

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

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.

Lot / code: Lot, expiry: Lot 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lot 159, exp 4/22/26; Lot 176, exp 7/24/26; Lot 177, exp 7/28/26; Lot 178, exp 7/31/26; Lot 179, exp 8/05/26.

Quantity: 14,333 cases (24 cartons per case)

Reason for recall

cGMP deviations and lack of assurance of sterility.

Recall record

Recall number: D-0408-2025
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): POLYVINYL ALCOHOL
Generic name(s): POLYVINYL ALCOHOL
Manufacturer(s): AvPAK
NDC(s): 50268-678
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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