Why it was recalled
cGMP deviations and lack of assurance of sterility.
Product description
Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0405-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 23, 2025
- FDA report date
- May 14, 2025
- Quantity
- 1,610 cases (24 cartons per case)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- BRS Analytical Services, LLC
Original FDA data
Every field from FDA enforcement report D-0405-2025, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 96741
- Address
- 11697 Lakeside Crossing Ct
- Code information
- Lot, expiry: Lot 114, exp 9/04/25; Lot 115, exp 9/06/25; Lot 116, exp 9/10/25; Lot 207, exp 12/05/26
- Postal code
- 63146-8606
- Report date
- May 14, 2025
- Product type
- Drugs
- Recall number
- D-0405-2025
- Classification
- Class II
- Recalling firm
- BRS Analytical Services, LLC
- Product quantity
- 1,610 cases (24 cartons per case)
- Reason for recall
- cGMP deviations and lack of assurance of sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-066-15.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 23, 2025
- Initial firm notification
- Letter
- Center classification date
- May 6, 2025