PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 25, 2023 Initiated: October 13, 2022 #D-0152-2023

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:

Details

Recalling Firm
Akorn, Inc.
Units Affected
51,601 bottles
Distribution
Nationwide in the USA
Location
Gurnee, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Akorn, Inc.. Units affected: 51,601 bottles.
Why was this product recalled?
CGMP Deviations:
Which agency issued this recall?
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0152-2023.