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.
Quick Facts at a Glance
- Recall Date
- April 21, 2026
- Hazard Level
- HIGH
- Brands
- GENTEAL TEARS, Alcon Laboratories, Inc.
- Geographic Scope
- 1 states
Hazard Information
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Alcon Research LLC or your healthcare provider for guidance. Notification method: Letter
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Full Description
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.. Generic: HYPROMELLOSE; Brand: GENTEAL TEARS. Reason: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.. Classification: Class II. Distribution: Nationwide within the United States
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