Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx ...
FDA Recall #D-1388-2020 — Class III — December 26, 2019
Product Description
Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12
Reason for Recall
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Recalling Firm
Akorn, Inc. — Lake Forest, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
33,343 bottles
Distribution
Nationwide USA and Puerto Rico
Code Information
Lot 9E52A, exp 04/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated