Akorn, Inc. 2022-09-14 Health serious FDA
Health · FDA · Recall #FDA-D-1496-2022
Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by:… Recall
Issued September 14, 2022 · Akorn, Inc.
In September 2022, Akorn, Inc. recalled the Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by:…, 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: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
What you should do
- 1 Stop using Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) tube, Mfg by:… 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
- September 14, 2022
- Units affected
- Not reported
- Sold at
- USA nationwide
- Recall number
- FDA-D-1496-2022
- 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 870th Health recall we've logged in 2022.