Class II
Terminated
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.
This recall has been terminated (originally issued February 24, 2016).
- Company
- Alcon Research, Ltd.
- Recall Initiated
- February 9, 2016
- Posted
- February 24, 2016
- Recall Number
- D-0666-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 12,648 cartons
- Firm Location
- Fort Worth, TX, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide
Lot / Code Info
Lot #: KRJ006, Exp 09/17
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