FDA Drug recall D-0666-2016
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…
- FDA Drug
- Class II
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class II recall of 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… by Alcon Research, citing 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 via….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0666-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-09 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Alcon Research |
| Distribution | US |
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.
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.
Identifiers
| upc | 300650416368 |
|---|---|
| code_info | Lot #: KRJ006, Exp 09/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0666-2016%22
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