D-0152-2023 Class II Ongoing

Recalled by Akorn, Inc. — Gurnee, IL

Recall Details

Product Type
Drugs
Report Date
January 25, 2023
Initiation Date
October 13, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
51,601 bottles

Product Description

PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12

Reason for Recall

CGMP Deviations:

Distribution Pattern

Nationwide in the USA

Code Information

Lot: 0B55A, EXP 1/31/2023; 0D16A, 0D23A, EXP 3/31/2023; 0E51A, EXP 4/30/2023; 1C46A, EXP 2/29/2024;