Timolol Maleate Ophthalmic Solution recall: Impurity Out of Spec
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.…
Why was Timolol Maleate Ophthalmic Solution recalled?
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 9N72, EXP 09/30/2022
- Product
- Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045.…
- Recalling firm
- Akorn, Inc
- Quantity
- 5,226 Cartons (60 vials/carton)
- Distribution
- Distributed Nationwide in the USA
- Recall date
- September 7, 2022
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)