URGENT: Recall Notice

Re: Ophthalmic Recall

Recall Notice Form

Date: May 14, 2025

Dear Valued Customer,

We are assisting BRS Analytical Service, LLC. In a Voluntary Recall. This has changed to the RETAIL LEVEL ONLY. This recall has been initiated due to manufacturing cGMP deviations identified during an audit by FDA. Health Hazard to the user is unknown, cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products. The below marketed products are subject to the recall.

NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
Lot Number Expiry Date Quantity to Return
012610/26/25
012710/30/25
012811/02/25
012911/06/25
016205/09/26
016305/14/26
016405/20/26
016505/23/26
016605/29/26
016706/03/26
NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
Lot Number Expiry Date Quantity to Return
016806/06/26
016906/10/26
017006/13/26
019310/07/26
019410/10/26
019510/14/26
019610/17/26
019710/21/26
019810/24/26
019910/30/26
NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Lot Number Expiry Date Quantity to Return
011409/04/25
011509/06/25
NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
Lot Number Expiry Date Quantity to Return
011609/10/25
020712/05/26
NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lot Number Expiry Date Quantity to Return
010304/26/25
010405/03/25
010806/29/25
010907/18/25
011008/17/25
011108/22/25
011208/27/25
011309/18/25
012510/23/25
013011/09/25
013111/14/25
013211/27/25
013311/30/25
013412/05/25
013512/11/25
013612/14/25
013701/02/26
013901/15/26
014001/19/26
014101/25/26
015103/18/26
015203/21/26
015303/25/26
015403/28/26
NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lot Number Expiry Date Quantity to Return
015504/08/26
015604/08/26
015704/11/26
016004/26/26
018008/08/26
018108/12/26
018208/18/26
018308/21/26
018408/26/26
018509/04/26
018609/09/26
018709/16/26
018909/21/26
019009/25/26
019109/28/26
019210/02/26
020812/11/26
020912/16/26
021201/15/27
021301/21/27
021401/24/27
021502/02/27
021602/04/27
022403/27/27
NDC# 50268-126-15 Lubricant Eye Drops Solution
Lot Number Expiry Date Quantity to Return
011709/20/25
011809/25/25
011909/27/25
012110/05/25
016105/01/26
017106/18/26
017206/24/26
017407/01/26
017507/08/26
020011/05/26
NDC# 50268-126-15 Lubricant Eye Drops Solution
Lot Number Expiry Date Quantity to Return
020111/10/26
020211/13/26
020311/18/26
020411/21/26
020511/25/26
020612/02/26
021902/24/27
022103/02/27
022203/05/27
   
NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
Lot Number Expiry Date Quantity to Return
012010/02/25
012210/09/25
012310/12/25
012410/16/25
013810/08/26
014212/09/26
014302/01/26
014402/07/26
014502/12/26
014602/15/26
NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
Lot Number Expiry Date Quantity to Return
014702/21/26
014802/27/26
014903/04/26
015003/11/26
015804/15/26
015904/22/26
017607/24/26
017707/28/26
017807/31/26
017908/05/26

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