FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., La
Summary
The FDA issued a Class II for FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per c by Nomax Inc. Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current .
Details
Source
Drug Recall
External ID
D-0465-2024
Action Date
2024-05-01
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot #: 14776, Exp. 05/31/2024.
Quantity Affected: 15,444 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.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-19
Company
Saint Louis, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 96 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Nomax Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nomax Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nomax Inc have FDA actions?
Nomax Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0465-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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