Proparacaine HCl Ophthalmic Solution recall: CGMP Deviations
Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Why was Proparacaine HCl Ophthalmic Solution recalled?
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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?
All Lots
- Product
- Proparacaine HCl Ophthalmic Solution, USP 0.5%, 15 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Recalling firm
- Akorn, Inc.
- Quantity
- N/A
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- June 7, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)