Leiters Health recalls lidocaine and phenylephrine vials with glass delamination risk. Affected vials have specific lot numbers and expiration dates. Stop using immediately.
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Leiters Health is recalling lidocaine and phenylephrine vials that may contain glass particles due to manufacturing defects. This could cause injury if injected. Affected vials have specific lot numbers and expiration dates.
Glass vials from the manufacturer showed signs of glass delamination, meaning small glass particles could break off during use. If injected, these particles could cause serious injury or tissue damage.
Prescription users of lidocaine and phenylephrine vials. Those with the specific lot numbers and expiration dates listed are most at risk.
Check for vials labeled 'Lidocaine HCL 1% (10mg/mL), Phenylephrine HCL 1.5% (15mg/mL), 1 ml in a Single-Dose Vial, RX Only, Leiters 13796'. Look for lot numbers 2331104 through 2331500 with expiration dates up to May 2024.
Discard the vial if you have the affected lot numbers listed in the recall notice.
Lot numbers 2331104, 2331137, 2331196, 2331264, 2331282, 2331464, 2331481, 2331500.
Expiration dates range from March 9, 2024, to May 20, 2024.
The recall does not specify a return process; discard the vial immediately.
We’ve drafted a message you can send Leiters Health to request your refund or repair — edit it as you like.
Subject: Recall D-0363-2024 — Leiters Health Leiters Health Hello, I own a Leiters Health that is covered by recall D-0363-2024 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.
