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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Timolol Maleate Ophthalmic Solution Recalled for Defective Bottle Container

Agency Publication Date: January 31, 2025
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Summary

FDC Limited is recalling approximately 118,104 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% (5mL), distributed by Rising Pharmaceuticals Inc. The recall is due to a container defect where a plastic spike from the cap becomes lodged inside the bottle's nozzle. This defect prevents the liquid medication from being dispensed, which may lead patients to miss their prescribed doses.

Risk

The defective container makes it impossible to get the solution out of the bottle. For patients relying on this medication to treat conditions like glaucoma or ocular hypertension, a blocked nozzle could lead to missed doses and poorly controlled eye pressure.

What You Should Do

  1. This recall affects 5mL bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% (NDC 64980-514-05) from lot number 083J033 with an expiration date of September 2025.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact FDC Limited or Rising Pharmaceuticals Inc for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Timolol Maleate Ophthalmic Solution USP, 0.5% (5mL)by Rising Pharmaceuticals Inc
Variants: 0.5%, Sterile, 5mL bottles
Lot Numbers:
083J033 (Exp 09/2025)
NDC:
64980-514-05

Manufactured by FDC Limited; Distributed by Rising Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96196
Status: Active
Manufacturer: FDC Limited
Sold By: Rising Pharmaceuticals Inc; Retail pharmacies
Manufactured In: India
Units Affected: 118104 bottles
Distributed To: New Jersey

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.