Why it was recalled
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.
Product description
TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8.
Lot numbers, UPCs & expiration codes
Lot #: KRJ006, Exp 09/17
Where it was sold
Nationwide
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-0666-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2016
- FDA report date
- Feb 24, 2016
- Quantity
- 12,648 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alcon Research, Ltd.
Original FDA data
Every field from FDA enforcement report D-0666-2016, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 73275
- Address
- 6201 South Fwy
- Code information
- Lot #: KRJ006, Exp 09/17
- Postal code
- 76134-2099
- Report date
- Feb 24, 2016
- Product type
- Drugs
- Recall number
- D-0666-2016
- Classification
- Class II
- Recalling firm
- Alcon Research, Ltd.
- Product quantity
- 12,648 cartons
- Termination date
- Apr 13, 2017
- Reason for recall
- Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- TEARS Naturale FREE (dextran 70 and hypromellose 2910) lubricant eye drops, 1% and 0.3%, Preservative Free, 0.9 mL (0.03 FL OZ) Single-Use Vials, packaged in 60-count Single-Use Vials per carton, Manufactured for: Alcon Laboratories, Inc., Fort Work, TX 76134, Barcode 90016741106, UPC 3 00650 41636 8.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 9, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 16, 2016