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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

DrugsSource: FDA (drug) · Date: 2026-05-06

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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
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