Alcon Research LLC: GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 00
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Alcon Research LLC
- Product
- 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.
- Reason / hazard
- Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2026-04-21
- Code info
- 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.
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Fort Worth
- State
- TX
- Country
- United States
- Event id
- 98815
Free daily digest + "My products" watchlist