FDA recall D-0465-2024

Nomax Inc · Class II · drug

Product

FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.

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.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-04-19
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Louis, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0465-2024