Akorn, Inc. 2023-06-07 Health serious FDA
Health · FDA · Recall #FDA-D-0785-2023
Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed… Recall
Issued June 7, 2023 · Akorn, Inc.
In June 2023, Akorn, Inc. recalled the Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
What you should do
- 1 Stop using Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only, Distributed… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Akorn, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Akorn, Inc.
- Category
- Health
- Recall date
- June 7, 2023
- Units affected
- Not reported
- Sold at
- Nationwide in the USA and Puerto Rico
- Recall number
- FDA-D-0785-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Akorn, Inc. has 63 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.