FDARecalled May 6, 2026 · #D-0491-2026
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
Hazard
Class II — temporary health risk
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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
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Alcon Research LLC
- Model numbers
- 9T21, 1U63, 6V00, 9V55, 1W39, 1X76
- UPCs
- —