Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
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
- SYSTANE, 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
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01. Generic: HYPROMELLOSE; Brand: SYSTANE. 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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