Akorn, Inc 2022-09-07 Health moderate FDA
Health · FDA · Recall #FDA-D-1471-2022
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only,… Recall
Issued September 7, 2022 · Akorn, Inc
In September 2022, Akorn, Inc recalled the Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only,…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
What you should do
- 1 Stop using Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only,… 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 7, 2022
- Units affected
- Not reported
- Sold at
- Distributed Nationwide in the USA
- Recall number
- FDA-D-1471-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Akorn, Inc has 2 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.