Updated: SUB-RECALLURGENT: Voluntary Drug Recall Notice Re: Ophthalmic Recall
We have been notified that BRS Analytical Service, LLC. is initiating 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.
We request that you complete “Quantity to Return” section and the Customer information block below. Please fax to 931-292-6229 or email customerservice@avkare.com. Even if the quantity is zero.Download a PDF copy of this recall notice to fill in and fax back to us.
- NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
- NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
- NDC# 50268-126-15 Lubricant Eye Drops Solution
- NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
This recall is being carried out with the knowledge of the US Food and Drug Administration. Further use of this product should immediately cease.
These items were first shipped May 26, 2023, until April 21, 2025
Please examine your inventory to determine if you have any of the lot’s listed below. If so, immediately discontinue use and remove it from active inventory.
| NDC & Product Description | NDC & Product Description | ||||
|---|---|---|---|---|---|
| NDC 50268-043-15 Artificial Tears Ophthalmic Solution | Quantity to Return | NDC 50268-043-15 Artificial Tears Ophthalmic Solution | Quantity to Return | ||
| Lot # & Expiration Date | Lot # & Expiration Date | ||||
| Lot: 0126 | Exp. 10/26/25 | Lot: 0168 | Exp. 06/06/26 | ||
| Lot: | Exp. 10/30/25 | Lot: 0169 | Exp. 06/10/26 | ||
| Lot: 0128 | Exp. 11/02/25 | Lot: 0170 | Exp. 06/13/26 | ||
| Lot: 0129 | Exp. 11/06/25 | Lot: 0193 | Exp. 10/07/26 | ||
| Lot: 0162 | Exp. 05/09/26 | Lot: 0194 | Exp. 10/10/26 | ||
| Lot: 0163 | Exp. 05/14/26 | Lot: 0195 | Exp. 10/14/26 | ||
| Lot: 0164 | Exp. 05/20/26 | Lot: 0196 | Exp. 10/17/26 | ||
| Lot: 0165 | Exp. 05/23/26 | Lot: 0197 | Exp. 10/21/26 | ||
| Lot: 0166 | Exp. 05/29/26 | Lot: 0198 | Exp. 10/24/26 | ||
| Lot: 0167 | Exp. 06/03/26 | Lot: 0199 | Exp. 10/30/26 | ||
| NDC & Product Description | NDC & Product Description | ||||
|---|---|---|---|---|---|
| NDC 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% | Quantity to Return | NDC 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% | Quantity to Return | ||
| Lot # & Expiration Date | Lot # & Expiration Date | ||||
| Lot: 0114 | Exp. 09/04/25 | Lot: 0116 | Exp. 09/10/25 | ||
| Lot: 0115 | Exp. 09/06/25 | Lot: 0207 | Exp. 12/05/26 | ||
| NDC & Product Description | NDC & Product Description | ||||
|---|---|---|---|---|---|
| NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% | Quantity to Return | NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% | Quantity to Return | ||
| Lot # & Expiration Date | Lot # & Expiration Date | ||||
| Lot: 0103 | Exp. 04/26/25 | Lot: 0155 | Exp. 04/08/26 | ||
| Lot: 0104 | Exp. 05/03/25 | Lot: 0156 | Exp. 04/08/26 | ||
| Lot: 0108 | Exp. 06/29/25 | Lot: 0157 | Exp. 04/11/26 | ||
| Lot: 0109 | Exp. 07/18/25 | Lot: 0160 | Exp. 04/26/26 | ||
| Lot: 0110 | Exp. 08/17/25 | Lot: 0180 | Exp. 08/08/26 | ||
| Lot: 0111 | Exp. 08/22/25 | Lot: 0181 | Exp. 08/12/26 | ||
| Lot: 0112 | Exp. 08/27/25 | Lot: 0182 | Exp. 08/18/26 | ||
| Lot: 0113 | Exp. 09/18/25 | Lot: 0183 | Exp. 08/21/26 | ||
| Lot: 0125 | Exp. 10/23/25 | Lot: 0184 | Exp. 08/26/26 | ||
| Lot: 0130 | Exp. 11/09/25 | Lot: 0185 | Exp. 09/04/26 | ||
| Lot: 0131 | Exp. 11/14/25 | Lot: 0186 | Exp. 09/09/26 | ||
| Lot: 0132 | Exp. 11/27/25 | Lot: 0187 | Exp. 09/16/26 | ||
| Lot: 0133 | Exp. 11/30/25 | Lot: 0189 | Exp. 09/21/26 | ||
| Lot: 0134 | Exp. 12/05/25 | Lot: 0190 | Exp. 09/25/26 | ||
| Lot: 0135 | Exp. 12/11/25 | Lot: 0191 | Exp. 09/28/26 | ||
| Lot: 0136 | Exp. 12/14/25 | Lot: 0192 | Exp. 10/02/26 | ||
| Lot: 0137 | Exp. 01/02/26 | Lot: 0208 | Exp. 12/11/26 | ||
| Lot: 0139 | Exp. 01/15/26 | Lot: 0209 | Exp. 12/16/26 | ||
| Lot: 0140 | Exp. 01/19/26 | Lot: 0212 | Exp. 01/15/27 | ||
| Lot: 0141 | Exp. 01/25/26 | Lot: 0213 | Exp. 01/21/27 | ||
| Lot: 0151 | Exp. 03/18/26 | Lot: 0214 | Exp. 01/24/27 | ||
| Lot: 0152 | Exp. 03/21/26 | Lot: 0215 | Exp. 02/02/27 | ||
| Lot: 0153 | Exp. 03/25/26 | Lot: 0216 | Exp. 02/04/27 | ||
| Lot: 0154 | Exp. 03/28/26 | Lot: 0224 | Exp. 03/27/27 | ||
| NDC & Product Description | NDC & Product Description | ||||
|---|---|---|---|---|---|
| NDC# 50268-126-15 Lubricant Eye Drops Solution | Quantity to Return | NDC# 50268-126-15 Lubricant Eye Drops Solution | Quantity to Return | ||
| Lot # & Expiration Date | Lot # & Expiration Date | ||||
| Lot: 0117 | Exp. 09/20/25 | Lot: 0201 | Exp. 11/10/26 | ||
| Lot: 0118 | Exp. 09/25/25 | Lot: 0202 | Exp. 11/13/26 | ||
| Lot: 0119 | Exp. 09/27/25 | Lot: 0203 | Exp. 11/18/26 | ||
| Lot: 0121 | Exp. 10/05/25 | Lot: 0204 | Exp. 11/21/26 | ||
| Lot: 0161 | Exp. 05/01/26 | Lot: 0205 | Exp. 11/25/26 | ||
| Lot: 0171 | Exp. 06/18/26 | Lot: 0206 | Exp. 12/02/26 | ||
| Lot: 0172 | Exp. 06/24/26 | Lot: 0219 | Exp. 02/24/27 | ||
| Lot: 0174 | Exp. 07/01/26 | Lot: 0221 | Exp. 03/02/27 | ||
| Lot: 0175 | Exp. 07/08/26 | Lot: 0222 | Exp. 03/05/27 | ||
| Lot: 0200 | Exp. 11/05/26 | ||||
| NDC & Product Description | NDC & Product Description | ||||
|---|---|---|---|---|---|
| NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution | Quantity to Return | NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution | Quantity to Return | ||
| Lot # & Expiration Date | Lot # & Expiration Date | ||||
| Lot: 0120 | Exp. 10/02/25 | Lot: 0147 | Exp. 02/21/26 | ||
| Lot: 0122 | Exp. 10/09/25 | Lot: 0148 | Exp. 02/27/26 | ||
| Lot: 0123 | Exp. 10/12/25 | Lot: 0149 | Exp. 03/04/26 | ||
| Lot: 0124 | Exp. 10/16/25 | Lot: 0150 | Exp. 03/11/26 | ||
| Lot: 0138 | Exp. 10/08/26 | Lot: 0158 | Exp. 04/15/26 | ||
| Lot: 0142 | Exp. 12/09/26 | Lot: 0159 | Exp. 04/22/26 | ||
| Lot: 0143 | Exp. 02/01/26 | Lot: 0176 | Exp. 07/24/26 | ||
| Lot: 0144 | Exp. 02/07/26 | Lot: 0177 | Exp. 07/28/26 | ||
| Lot: 0145 | Exp. 02/12/26 | Lot: 0178 | Exp. 07/31/26 | ||
| Lot: 0146 | Exp. 02/15/26 | Lot: 0179 | Exp. 08/05/26 | ||
IF YOU HAVE PREVIOUSLY SENT A REQUEST FORR A RETURN AUTHORIZATION, PLEASE ALLOW EXTRA TIME FOR THE RESPONSE.
Once you fax your response, we will send you a Return Authorization Form (RA). Please return any recalled product that was purchased from AvKARE to the following address. Also, include a copy of letter in your return package. Mark the shipping container: Ophthalmic RECALL.
R&S Northeast LLC8407 Austin Tracy RdFountain Run, KY 42133
We will issue full credit including shipping cost for any returns. If you have any question on this matter, please contact us. We regret any inconvenience that this may cause.
