Recalls / Class II
Class IID-1320-2022
Product
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
- Brand name
- Genteal
- Generic name
- Mineral Oil, White Petrolatum
- Active ingredients
- Mineral Oil, Petrolatum
- Route
- Ophthalmic
- NDC
- 0065-0518
- FDA application
- M018
- Affected lot / code info
- Part# 30065051801
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
- 40 boxes
- 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-1320-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.