Drug Enforcement D-0464-2024

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Status

Ongoing

Classification

Class II

Report Date

May 1, 2024

Termination Date

—

Product Information

Product description
FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
Product quantity
4648 cartons
Reason for recall
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Nomax Inc
Address
9735 Green Park Industrial Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0464-2024
Event ID
94461
Recall initiation date
April 19, 2024
Center classification date
April 23, 2024
Code info
Lot 14842, Exp. 6/30/2024
More code info
—