April 2024 FDA Recall Timolol Maleate by Fdc Limited
D-0488-2024 - Defective Container

This Class II drug recall was voluntarily initiated by Fdc Limited on April 25, 2024 for the product Timolol Maleate. The FDA reported the reason for recall as defective container. The product was distributed in New Jersey Only and the recall is currently terminated.

Recall Number: D-0488-2024

Reason for Recall
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Initiated
04-25-2024
Reported
05-15-2024
Quantity
382,104 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94466
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FDC Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
New Jersey Only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-21-2026
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.

Affected Packages Involved in this Recall

64980-513-05 Timolol Maleate
64980-513-01 Timolol Maleate
64980-513-15 Timolol Maleate
64980-514-05 Timolol Maleate
64980-514-01 Timolol Maleate
64980-514-15 Timolol Maleate