Recalls / Class II

Class IID-0464-2024

Product

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.

Affected lot / code info

Lot 14842, Exp. 6/30/2024

Why it was recalled

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.

Recalling firm

Firm

Nomax Inc

Notification channel

N/A

Type

Voluntary: Firm initiated

Address

9735 Green Park Industrial Dr, N/A, Saint Louis, Missouri 63123-7241

Distribution

Quantity

4648 cartons

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2024-04-19

FDA classified

2024-04-23

Posted by FDA

2024-05-01

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0464-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.