FDAClass IIIJuly 22, 2020

Proparacaine Hydrochloride Ophthalmic Solution recall: Contamination

Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL…

Why was Proparacaine Hydrochloride Ophthalmic Solution recalled?

Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

What should I do if I have this product?

Review the official FDA enforcement record for current 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 9E52A, exp 04/2021

Product
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL…
Recalling firm
Akorn, Inc.
Quantity
33,343 bottles
Distribution
Nationwide USA and Puerto Rico
Recall date
July 22, 2020
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls