Why it was recalled
cGMP deviations and lack of assurance of sterility.
Product description
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 numbers, UPCs & expiration codes
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.
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-0408-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 23, 2025
- FDA report date
- May 14, 2025
- Quantity
- 14,333 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-0408-2025, 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 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.
- Postal code
- 63146-8606
- Report date
- May 14, 2025
- Product type
- Drugs
- Recall number
- D-0408-2025
- Classification
- Class II
- Recalling firm
- BRS Analytical Services, LLC
- Product quantity
- 14,333 cases (24 cartons per case)
- Reason for recall
- cGMP deviations and lack of assurance of sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 23, 2025
- Initial firm notification
- Letter
- Center classification date
- May 6, 2025