GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Official details
- Category
- Drug recall
- Status
- Ongoing
- Classification
- Class II
- Company or vendor
- Alcon Research LLC
- Affected product
- Nationwide within the United States
- Risk or reason
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Remedy or action
- Lot #: 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
- Official ID
- D-0492-2026