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Serious recall: Injury is possible or has been reported. Take action promptly.

FDC Limited 2024-11-13 Health serious FDA
Health · FDA · Recall #FDA-D-0035-2025

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,… Recall

Issued November 13, 2024 · FDC Limited

In November 2024, FDC Limited recalled the Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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

What you should do

  1. 1 Stop using Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact FDC Limited to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
FDC Limited
Category
Health
Recall date
November 13, 2024
Units affected
Not reported
Sold at
Distributed to one Us Distributor in NJ.
Recall number
FDA-D-0035-2025
Made in
India
Issuing agency
FDA

In context

  • FDC Limited has 7 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 737th Health recall we've logged in 2024.
Read the official FDA notice

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