Drug product
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.
D-0666-2016
Product summary
- Event
- Event 73275
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,648 cartons
- Official record key
drug-enforcement:D-0666-2016
Official wording
Reason: 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.
Code information: Lot #: KRJ006, Exp 09/17
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility