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Recall Observatory FDA recall evidence

Drug 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.

D-0492-2026

April 21, 2026

Class II

Product summary

Firm
Alcon Research LLC
Event
Event 98815
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0492-2026

Official wording

Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Code information: 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.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility