Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn
Summary
The FDA issued a Class III for Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx by Akorn, Inc. Reason: Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point..
Details
Source
Drug Recall
External ID
D-1471-2022
Action Date
2022-09-07
Status
Ongoing
Category
drug
Product Description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
Lot/Code Info: Lot #: 9N72, EXP 09/30/2022
Quantity Affected: 5,226 Cartons (60 vials/carton)
Reason for Recall
Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-08
Company
Gurnee, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 133 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Akorn, Inc has 130 FDA actions in our database, including 130 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Akorn, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Akorn, Inc have FDA actions?
Akorn, Inc has 130 FDA actions in our database, including 130 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1471-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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