Leiters Health recalls phenylephrine HCl 1mg per 10mL syringes due to CGMP deviations. These prescription syringes may have manufacturing issues affecting safety.
CGMP DEVIATIONS
Leiters Health is recalling phenylephrine HCl 1mg per 10mL syringes (Rx only) because of manufacturing deviations. This recall affects specific lots produced between March and July 2023. The issue could potentially impact product safety, though the exact risk is not specified in the recall notice.
The recall cites CGMP deviations, which are manufacturing quality control failures. These deviations could lead to unsafe product conditions, but the specific hazard mechanism isn't detailed in the notice. The recall does not specify if the issue causes injury or how it affects the product.
Prescription users of phenylephrine HCl syringes who purchased the affected lots from Leiters Health in Englewood, Colorado. People using these syringes for medical purposes are most at risk.
Check for the product name 'Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes' with the manufacturer Leiters Health. Look for the lot numbers listed in the recall: 2230895 through 2330025, produced between March and July 2023.
Identify the lot number and expiration date on the syringe to see if it matches the recalled lots listed in the notice.
The recall is due to CGMP deviations, which are manufacturing quality control issues. The exact nature of the deviation is not specified in the notice.
The recall does not provide a specific remedy. Check the lot number against the listed numbers to see if it's affected, then contact Leiters Health for further instructions.
The recall does not specify the hazard mechanism or potential risks. The exact danger level is unknown based on the information provided.
We’ve drafted a message you can send Leiters Health to request your refund or repair — edit it as you like.
Subject: Recall D-0443-2023 — Leiters Health Leiters Health Hello, I own a Leiters Health that is covered by recall D-0443-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
