Recalls / Class II
Class IID-1314-2022
Product
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.
- Brand name
- Systane Lubricant
- Generic name
- Polyethylene Glycol 400 And Propylene Glycol
- Active ingredients
- Polyethylene Glycol 400, Propylene Glycol
- Route
- Ophthalmic
- NDC
- 0065-0429
- FDA application
- M018
- Affected lot / code info
- Part# a) 0065042915, b) 0065042930
Why it was recalled
CGMP Deviations: products were stored outside the drug label specifications.
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Alcon Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 47 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2022-06-29
- FDA classified
- 2022-08-05
- Posted by FDA
- 2022-08-17
- Terminated
- 2024-02-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1314-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.