Leiters Health recalls specific Moxifloxacin PF vials due to glass delamination causing particulate matter. Affected vials have lot numbers ending in 31147-31563 with expiration dates through April 2024.
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Leiters Health is recalling certain Moxifloxacin PF vials that may contain glass particles from delamination. This could cause serious eye injury if used during intracameral procedures.
Glass vials showed signs of delamination, which can release particles into the solution. These particles could enter the eye during surgery, potentially causing injury.
Patients receiving intracameral eye injections with the recalled vials are at risk. Healthcare providers using these vials for eye surgery may need to switch to alternative products.
Check for vial lot numbers ending in 31147, 31180, 31256, 31279, 31283, 31345, 31422, or 31563 with expiration dates through April 2024.
Look for lot numbers ending in 31147, 31180, 31256, 31279, 31283, 31345, 31422, or 31563 on the vial label.
The vials showed signs of glass delamination, which can release particles into the solution.
The recall record does not specify a remedy, so contact Leiters Health directly for guidance.
Yes, glass particles could enter the eye during surgery, potentially causing injury.
We’ve drafted a message you can send Leiters Health to request your refund or repair — edit it as you like.
Subject: Recall D-0361-2024 — Leiters Health Leiters Health Hello, I own a Leiters Health that is covered by recall D-0361-2024 from Leiters Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
