Drugs & medicalClass II

FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad,…

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Read the official notice →
Date
2025-02-12
Country
United States
Brand
FDC
Product
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad,…
Classification
Class II
Units
Distributed to one (1) Us Distributor in NJ
Category
Drugs & medical
Source
FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More FDC recalls

  1. 2025-08-06
  2. US
    Drugs & medicalClass II

    FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad,…

    Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

    FDA · DrugFDC LimitedU.S Nationwide.Official notice →
  3. 2025-05-14
  4. US
    Drugs & medicalClass II

    FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad,…

    Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

    FDA · DrugFDC LimitedU.S. NationwideOfficial notice →
  5. 2025-03-26
  6. US
    Drugs & medicalClass II

    FDC Limited recalls Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ.…

    Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

    FDA · DrugFDC LimitedNationwide in the U.SOfficial notice →
  7. 2025-01-15
  8. US
    Drugs & medicalClass II

    FDC Limited recalls Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC,…

    Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

    FDA · DrugFDC LimitedNationwideOfficial notice →
  9. 2024-12-18
  10. US
    Drugs & medicalClass II

    FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad,…

    Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

    FDA · DrugFDC LimitedDistributed to one Us Distributor in NJ.Official notice →
  11. 2024-11-13
  12. US
    Drugs & medicalClass II

    FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad,…

    Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

    FDA · DrugFDC LimitedDistributed to one Us Distributor in NJ.Official notice →
All 11 FDC recalls →

Other drugs & medical recalls in the United States

  1. 2025-02-12
  2. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA, Inc recalls Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC…

    Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit

    FDA · DrugTeva Pharmaceuticals USA, IncProduct was distributed nationwide.Official notice →
  3. US
    Drugs & medicalClass II

    RemedyRepack Inc. recalls Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged…

    CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

    FDA · DrugRemedyRepack Inc.FLOfficial notice →
  4. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured…

    CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide in the U.SOfficial notice →
  5. 2025-02-05
  6. US
    Drugs & medicalClass II

    Murata Vios, Inc. recalls muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central…

    FDA · DeviceMurata Vios, Inc.Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the…Official notice →
  7. US
    Drugs & medicalClass II

    LivaNova USA, Inc. recalls Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description:…

    Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.

    FDA · DeviceLivaNova USA, Inc.Worldwide - US Nationwide distribution including in the states of AK, AZ, CA,…Official notice →
  8. US
    Drugs & medicalClass II

    Draeger Medical Systems, Inc. recalls Infinity Central Station. Model Number: MS26800 The Infinity CentralStation (ICS) is intended for centralized monitoring of adult,…

    Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the patient.

    FDA · DeviceDraeger Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AL, AS, AZ, CA, CO,…Official notice →
See all drugs & medical recalls →