Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL droppe
Summary
The FDA issued a Class II for Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bot by Akorn, Inc.. Reason: CGMP Deviations:.
Details
Source
Drug Recall
External ID
D-0156-2023
Action Date
2023-01-25
Status
Ongoing
Category
drug
Product Description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
Lot/Code Info: Lot: (a) 0B50A, 0B69A, EXP 1/31/2023; 0C74A, EXP 2/28/2023; 0D04A, EXP 3/31/2023; 0E37A, EXP 4/30/2023; 0G07A, 0G82A, EXP 6/30/2023; 0H26A, 0H28A, 0H53A, 0H36A, EXP 7/31/2023; 0J64A, 0J58A, 0J66A, EXP 8/31/2023; 0K96A, 0K06A, 0K98A, 0K04A, 0K03A, 0K99A, EXP 9/30/2023; 0L72A, EXP 10/31/2023; 0M81A, 0M85A, 0M80A, 0M84A, 0M82A, 0M83A, EXP 11/30/2023; 1A01A, 1A02A, EXP 12/31/2023; 1B16A, 1B13A, 1B17A, EXP 1/31/2024; 1C51A, EXP 2/29/2024; (b) 0B59A , EXP 1/31/2023;0E49A, EXP 4/30/2023; 0G14A, EXP 6/30/2023; 0H38A, EXP 7/31/2023; 0J84A, EXP 8/31/2023; 0K05A, EXP 9/30/2023; 0L59A, EXP 10/31/2023; 0M86A, 0M87A, EXP 11/30/2023; 1A03A, EXP 12/31/2023; 1B37A, EXP 1/31/2024; 1C63A, EXP 2/29/2024; 1C54A, EXP 2/29/2024; 1D83A, EXP 3/31/2024; (c) 0C82A, EXP 2/28/2023; 0G84A, EXP 6/30/2023; 0H49A, EXP 7/31/2023; 0J77A, EXP 8/31/2023; 0J75A, EXP 8/31/2023; 0L57A, EXP 10/31/2023; 0L74A, EXP 10/31/2023; 0L46A, EXP 10/31/2023; 1G52A, EXP 6/30/2024; 1J52A, EXP 8/31/2024;
Quantity Affected: 1,310,324 bottles
Reason for Recall
CGMP Deviations:
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-13
Company
Gurnee, IL
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 83 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 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 (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-0156-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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