Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC
Summary
The FDA issued a Class II for Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC by FDC Limited. Reason: Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers..
Details
Source
Drug Recall
External ID
D-0488-2024
Action Date
2024-05-15
Status
Terminated
Category
drug
Product Description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Lot/Code Info: Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
Quantity Affected: 382,104 units
Reason for Recall
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Distribution
New Jersey Only
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-25
Company
Aurangabad, Maharashtra State, N/A
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 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
FDC Limited has 11 FDA actions in our database, including 11 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 (FDC Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FDC Limited have FDA actions?
FDC Limited has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0488-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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